REMS Directory

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The REMS Directory is a comprehensive listing of factual information about Risk Evaluation and Mitigation Strategy (REMS) programs that have been required and approved by the FDA, with relevant information about the product for which the REMS was required.

We have provided access to comprehensive information on a select number of products below (). For additional information on other products listed, please contact us.

ACAM2000

Generic Name: Small pox (Vaccinia) Vaccine, Live		Status: Approved
NDA/BLA Holder: Acambis	NDA/BLA Number: BLA 125158	NDA/BLA Approval: 8/31/2007

Accutane

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: NDA 18-662	NDA/BLA Approval: 5/7/1982

Actiq

Generic Name: fentanyl citrate		Status: Approved
NDA/BLA Holder: Cephalon	NDA/BLA Number: NDA 20-747	NDA/BLA Approval: 11/4/1998

Actoplus Met

Generic Name: pioglitazone hydrochloride and metformin hydrochloride		Status: Approved
NDA/BLA Holder: Takeda	NDA/BLA Number: NDA 21-842/S-009	NDA/BLA Approval: 8/29/2005

Actoplus Met XR

Generic Name: pioglitazone hydrochloride and metformin hydrochloride extended-release		Status: Approved
NDA/BLA Holder: Takeda	NDA/BLA Number: NDA 22-024	NDA/BLA Approval: 5/12/2009

Actos

Generic Name: pioglitazone hydrochloride		Status: Approved
NDA/BLA Holder: Takeda	NDA/BLA Number: NDA 21-073/S-037	NDA/BLA Approval: 7/15/1999

Advair Diskus

Generic Name: fluticasone propionate and salmeterol xinafoate		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 21-077/S-029	NDA/BLA Approval: 8/24/2000

Advair HFA

Generic Name: fluticasone propionate and salmeterol xinafoate		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 21-254/S-007	NDA/BLA Approval: 6/8/2006

Amnesteem

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: ANDA 75-945	NDA/BLA Approval: Nov-02

Androgel

Generic Name: testosterone		Status: Approved
NDA/BLA Holder: Unimed Pharmaceuticals	NDA/BLA Number: NDA 21-015/S-022	NDA/BLA Approval: 2/28/2000

Aplenzin Extended-Release Tablets

Generic Name: bupropion hydrobromide		Status: Approved
NDA/BLA Holder: Biovail Labs	NDA/BLA Number: NDA 22-108	NDA/BLA Approval: 4/23/2008

Avandamet Tablets

Generic Name: rosiglitazone maleate and metformin hydrochloride		Status: Approved
NDA/BLA Holder: SB Pharmco	NDA/BLA Number: NDA 21-410/S-025	NDA/BLA Approval: 10/10/2002

Avandaryl Tablets

Generic Name: rosiglitazone maleate and glimepiride		Status: Approved
NDA/BLA Holder: SB Pharmco	NDA/BLA Number: NDA 21-700/S-008	NDA/BLA Approval: 11/23/2005

Avelox Tablets and I.V. Solution

Generic Name: moxifloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 21-085/S-042	NDA/BLA Approval: 12/10/1999

Avelox Tablets and I.V. Solution

Generic Name: moxifloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 21-277/S-036	NDA/BLA Approval: 11/30/2001

Banzel Tablets

Generic Name: rufinamide		Status: Approved
NDA/BLA Holder: Eisai Inc.	NDA/BLA Number: NDA 21-911	NDA/BLA Approval: 11/14/2008

Botox/Botox Cosmetic

Generic Name: onabotulinumtoxinA		Status: Approved
NDA/BLA Holder: Allergan	NDA/BLA Number: BLA 103000/5210, 5209	NDA/BLA Approval: 12/9/1991

Cambia

Generic Name: diclofenac potassium		Status: Approved
NDA/BLA Holder: Kowa	NDA/BLA Number: NDA 22-165	NDA/BLA Approval: 6/17/2009

Cimzia Lyophilized Powder for Solution for Subcutaneous Injection

Generic Name: certolizumab pegol		Status: Approved
NDA/BLA Holder: UCB	NDA/BLA Number: BLA 125160/0	NDA/BLA Approval: 4/22/2008

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 19-537/S-070	NDA/BLA Approval: 10/22/1987

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 19-847/S-044	NDA/BLA Approval: 12/26/1990

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 19-857/S-051	NDA/BLA Approval: 12/26/1990

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 20-780/S-028	NDA/BLA Approval: 9/26/1997

Cipro Tablets, Oral Suspension, I.V. Solution, and Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Bayer	NDA/BLA Number: NDA 21-473/S-025	NDA/BLA Approval: 12/13/2002

Claravis

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: ANDA 76-135	NDA/BLA Approval: Apr-03

Claravis

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: ANDA 76-356	NDA/BLA Approval: Apr-03

Clozaril

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Novartis Pharmaceuticals Corp.	NDA/BLA Number: NDA 19-758	NDA/BLA Approval: 9/26/1989

Clozaril

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Ivax Pharms	NDA/BLA Number: ANDA 74-949	NDA/BLA Approval: 11/26/1997

Clozaril

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Mylan Laboratories	NDA/BLA Number: ANDA 75-417	NDA/BLA Approval: 5/27/1999

Clozaril

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Caraco Pharmaceutical Laboratories	NDA/BLA Number: ANDA 75-713	NDA/BLA Approval: 11/15/2002

Clozaril

Generic Name: clozapine		Status: Discont'd
NDA/BLA Holder: Par Pharm	NDA/BLA Number: ANDA 75-162	NDA/BLA Approval: 4/26/2005

Clozaril

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Goldline	NDA/BLA Number: ANDA 76-809	NDA/BLA Approval: 12/16/2005

Colcrys

Generic Name: colchicine		Status: Approved
NDA/BLA Holder: Mutual Pharma	NDA/BLA Number: NDA 22-351	NDA/BLA Approval: 7/30/2009

Colcrys

Generic Name: colchicine		Status: Approved
NDA/BLA Holder: AR Holding Co, Inc.	NDA/BLA Number: NDA 22-352	NDA/BLA Approval: 7/29/2009

Colcrys

Generic Name: colchicine		Status: Approved
NDA/BLA Holder: Mutual Pharma	NDA/BLA Number: NDA 22-353	NDA/BLA Approval: 10/16/2009

Creon Delayed-Release Capsules

Generic Name: pancrelipase		Status: Approved
NDA/BLA Holder: Solvay	NDA/BLA Number: NDA 20-725	NDA/BLA Approval: 4/30/2009

Darvocet-N

Generic Name: acetaminophen; propoxyphene napsylate		Status: Approved
NDA/BLA Holder: Xanodyne	NDA/BLA Number: NDA 17-122/S-061, S-062	NDA/BLA Approval: 12/19/1972

Darvon

Generic Name: propoxyphene hydrochloride		Status: Approved
NDA/BLA Holder: Xanodyne	NDA/BLA Number: NDA 10-997/S-051, S-052	NDA/BLA Approval: 8/16/1957

Darvon-N

Generic Name: propoxyphene napsylate		Status: Approved
NDA/BLA Holder: Xanodyne	NDA/BLA Number: NDA 16-862/S-041, S-042	NDA/BLA Approval: 9/9/1971

Duetact

Generic Name: pioglitazone hydrochloride and glimepiride		Status: Approved
NDA/BLA Holder: Takeda	NDA/BLA Number: NDA 21-925/S-007	NDA/BLA Approval: 7/28/2006

Dysport Injection

Generic Name: abobotulinumtoxin A		Status: Approved
NDA/BLA Holder: Ipsen	NDA/BLA Number: BLA 125274/0, 125274/1	NDA/BLA Approval: 4/30/2009

Edluar Sublingual Tablets

Generic Name: zolpidem tartrate		Status: Approved
NDA/BLA Holder: Orexo AB	NDA/BLA Number: NDA 21-997	NDA/BLA Approval: 3/13/2009

Effexor XR Extended- Release Tablets

Generic Name: venlafaxine hydrochloride		Status: Approved
NDA/BLA Holder: Osmotica Pharm	NDA/BLA Number: NDA 22-104	NDA/BLA Approval: 5/20/2008

Effient

Generic Name: prasugrel		Status: Approved
NDA/BLA Holder: Eli Lilly and Company	NDA/BLA Number: NDA 22-307	NDA/BLA Approval: 7/10/2009

Enbrel for Subcutaneous Injection

Generic Name: etanercept		Status: Approved
NDA/BLA Holder: Immunex / Amgen	NDA/BLA Number: BLA 103795/5359	NDA/BLA Approval: 11/2/1998

Entereg Capsules

Generic Name: alvimopan		Status: Approved
NDA/BLA Holder: Adolor	NDA/BLA Number: NDA 21-775	NDA/BLA Approval: 5/20/2008

Epzicom Tablets

Generic Name: abacavir sulfate and lamivudine		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 21-652/S-008	NDA/BLA Approval: 8/2/2004

Extavia

Generic Name: interferon beta-1 b		Status: Approved
NDA/BLA Holder: Novartis	NDA/BLA Number: BLA 125290/0	NDA/BLA Approval: 8/14/2009

Factive Tablets

Generic Name: gemifloxacin		Status: Approved
NDA/BLA Holder: Oscient	NDA/BLA Number: NDA 21-158/S-014	NDA/BLA Approval: 4/4/2003

Fazaclo ODT

Generic Name: clozapine		Status: Approved
NDA/BLA Holder: Azur Pharma International	NDA/BLA Number: NDA 21-590	NDA/BLA Approval: 2/9/2004

Forteo

Generic Name: Teriparatide [rDNA origin]		Status: Approved
NDA/BLA Holder: Eli Lilly and Company	NDA/BLA Number: NDA 21-318	NDA/BLA Approval: 11/26/2002

Intron A

Generic Name: interferon alfa-2a		Status: Approved
NDA/BLA Holder: Schering	NDA/BLA Number: BLA 103132/5108	NDA/BLA Approval: 6/1/1986

Ionsys

Generic Name: fentanyl PCA		Status: Approved - Not Available in U.S. Market
NDA/BLA Holder: Alza	NDA/BLA Number: NDA 21-338	NDA/BLA Approval: 5/22/2006

Kaletra Oral Solution

Generic Name: lopinavir and ritonavir		Status: Approved
NDA/BLA Holder: Abbott	NDA/BLA Number: NDA 21-906/S-014	NDA/BLA Approval: 10/28/2005

Kaletra Oral Solution

Generic Name: lopinavir and ritonavir		Status: Approved
NDA/BLA Holder: Abbott	NDA/BLA Number: NDA 21-251/S-023	NDA/BLA Approval: 11/15/2000

Keppra, Keppra XR Tablets, Extended-Release Tablets, Oral Solution, and Injection

Generic Name: levetiracetam		Status: Approved
NDA/BLA Holder: UCB	NDA/BLA Number: NDA 21-035/S-078, S-080	NDA/BLA Approval: 11/30/1999

Keppra, Keppra XR Tablets, Extended-Release Tablets, Oral Solution, and Injection

Generic Name: levetiracetam		Status: Approved
NDA/BLA Holder: UCB	NDA/BLA Number: NDA 21-505/S-021, S-024	NDA/BLA Approval: 7/15/2003

Lamictal Tablets and Chewable Dispersible Tablets

Generic Name: lamotrigine		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 20-241/S-037, S-038	NDA/BLA Approval: 12/27/1994

Lamictal Tablets and Chewable Dispersible Tablets

Generic Name: lamotrigine		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 20-764/S-030, 031	NDA/BLA Approval: 8/24/1998

Letairis

Generic Name: ambrisentan		Status: Approved
NDA/BLA Holder: Gilead Sciences, Inc.	NDA/BLA Number: NDA 22-081	NDA/BLA Approval: 6/15/2007

Levaquin Tablets, Injection, and Oral Solution

Generic Name: levofloxacin		Status: Approved
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 20-634/ S-053	NDA/BLA Approval: 12/20/1996

Levaquin Tablets, Injection, and Oral Solution

Generic Name: levofloxacin		Status: Approved
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 20-635/ S-058	NDA/BLA Approval: 12/20/1996

Levaquin Tablets, Injection, and Oral Solution

Generic Name: levofloxacin		Status: Approved
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 21-721/ S-021	NDA/BLA Approval: 10/21/2004

Lotronex

Generic Name: alosetron		Status: Approved
NDA/BLA Holder: Prometheus Labs	NDA/BLA Number: NDA 21-107	NDA/BLA Approval: 2/9/2000

Lyrica Capsules

Generic Name: pregabalin		Status: Approved
NDA/BLA Holder: CP Pharms	NDA/BLA Number: NDA 21-446/S-013, S-014	NDA/BLA Approval: 12/30/2004

Mifeprex

Generic Name: mifepristone		Status: Approved
NDA/BLA Holder: Danco Laboratories	NDA/BLA Number: NDA 20-687	NDA/BLA Approval: 9/28/2000

Noroxin Tablets

Generic Name: norfloxacin		Status: Approved
NDA/BLA Holder: Merck	NDA/BLA Number: NDA 19-384/S-054	NDA/BLA Approval: 10/31/1986

Nplate for Subcutaneous Injection

Generic Name: romiplostim		Status: Approved
NDA/BLA Holder: Amgen	NDA/BLA Number: BLA 125268	NDA/BLA Approval: 8/22/2008

Nucynta

Generic Name: Tapentadol Tablets		Status: Approved Not Marketed
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 22-304	NDA/BLA Approval: 11/20/2008

Onsolis

Generic Name: fentanyl buccal soluble film		Status: Approved
NDA/BLA Holder: BioDelivery Science International Inc.	NDA/BLA Number: NDA 22-226	NDA/BLA Approval: 7/16/2009

Pegasys

Generic Name: peginterferon alfa-2a		Status: Approved
NDA/BLA Holder: Hoffman-La Roche	NDA/BLA Number: BLA 103964	NDA/BLA Approval: 10/16/2002

PegIntron

Generic Name: peginterferon alfa-2b		Status: Approved
NDA/BLA Holder: Schering	NDA/BLA Number: BLA 103949/5171, 5174	NDA/BLA Approval: 1/19/2001

PegIntron Rebetol Combopack Redipen Single-dose Delivery System and Rebetol Ribavirin

Generic Name: peginterferon alfa-2b,		Status: Approved
NDA/BLA Holder: Schering	NDA/BLA Number: BLA 125196/0	NDA/BLA Approval: 6/13/2008

Plenaxis

Generic Name: abarelix		Status: Discontinued
NDA/BLA Holder: Speciality European	NDA/BLA Number: NDA 21-320	NDA/BLA Approval: 11/25/2003

Promacta Tablets

Generic Name: eltrombopag		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 22-291	NDA/BLA Approval: 11/20/2008

Proquin XR Extended-Release Tablets

Generic Name: ciprofloxacin		Status: Approved
NDA/BLA Holder: Depomed Inc	NDA/BLA Number: NDA 21-744/S-012	NDA/BLA Approval: 5/19/2005

Revlimid

Generic Name: lenalidomide		Status: Approved
NDA/BLA Holder: Celgene	NDA/BLA Number: NDA 21-880	NDA/BLA Approval: 12/27/2005

Rozerem Tablets

Generic Name: ramelteon		Status: Approved
NDA/BLA Holder: Takeda	NDA/BLA Number: NDA 21-782/S-008, S-009, S-010	NDA/BLA Approval: 7/22/2005

Savella Tablets

Generic Name: milnacipran hydrochloride		Status: Approved
NDA/BLA Holder: Cypress Bioscience	NDA/BLA Number: NDA 22-256	NDA/BLA Approval: 1/14/2009

Simponi

Generic Name: golimumab		Status: Approved
NDA/BLA Holder: Centocor Ortho Biotech	NDA/BLA Number: BLA 125289	NDA/BLA Approval: 4/24/2009

Soliris

Generic Name: eculizumab		Status: Approved
NDA/BLA Holder: Alexion	NDA/BLA Number: BLA 125166	NDA/BLA Approval: 3/16/2007

Sotret

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: ANDA 76-041	NDA/BLA Approval: Dec-02

Sotret

Generic Name: isotretinoin		Status: Approved
NDA/BLA Holder: Hoffman LaRoche	NDA/BLA Number: ANDA 76-503	NDA/BLA Approval: Jun-03

Sucraid Oral Solution

Generic Name: sacrosidase		Status: Approved
NDA/BLA Holder: QOL Medical	NDA/BLA Number: NDA 20-772/S-005	NDA/BLA Approval: 4/9/1998

Symbicort Inhalation Aerosol

Generic Name: budesonide and formoterol		Status: Approved
NDA/BLA Holder: AstraZeneca	NDA/BLA Number: NDA 21-929/S-012	NDA/BLA Approval: 7/21/2006

Symbyax Capsules

Generic Name: olanzapine and fluoxetine		Status: Approved
NDA/BLA Holder: Eli Lilly	NDA/BLA Number: NDA 21-520/S-012	NDA/BLA Approval: 12/24/2003

Thalomid

Generic Name: thalidomide		Status: Approved
NDA/BLA Holder: Celgene	NDA/BLA Number: NDA 20-785	NDA/BLA Approval: 7/16/1998

Thalomid

Generic Name: thalidomide		Status: Approved
NDA/BLA Holder: Celgene	NDA/BLA Number: NDA 21-430	NDA/BLA Approval: 7/16/1998

Tikosyn

Generic Name: dofetilide		Status: Approved
NDA/BLA Holder: Pfizer	NDA/BLA Number: NDA 20-931	NDA/BLA Approval: 0/01/1999

Topamax Tablets and Sprinkle Capsules

Generic Name: topiramate		Status: Approved
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 20-505/S-038, S-039	NDA/BLA Approval: 12/24/1996

Topamax Tablets and Sprinkle Capsules

Generic Name: topiramate		Status: Approved
NDA/BLA Holder: Ortho McNeil Janssen	NDA/BLA Number: NDA 20-844/S-032, S-034	NDA/BLA Approval: 10/26/1998

Tracleer

Generic Name: bosentan		Status: Approved
NDA/BLA Holder: Actelion Pharmaceuticals US, Inc.	NDA/BLA Number: NDA 21-290	NDA/BLA Approval: 11/20/2001

Treximet Tablets

Generic Name: sumatriptan succinate and naproxen sodium		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 21-926	NDA/BLA Approval: 4/15/2008

Trilipix Delayed-Release Capsules

Generic Name: fenofibric acid		Status: Approved
NDA/BLA Holder: Abbott	NDA/BLA Number: NDA 22-224	NDA/BLA Approval: 12/15/2008

Trizivir

Generic Name: abacavir sulfate, lamivudine, and zidovudine		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 21-205/S-021	NDA/BLA Approval: 11/14/2000

Tysabri

Generic Name: natalizumab		Status: Approved
NDA/BLA Holder: Biogen Idec	NDA/BLA Number: BLA 125104	NDA/BLA Approval: 11/23/2004

Tyzeka Oral Solution

Generic Name: telbivudine		Status: Approved
NDA/BLA Holder: Novartis	NDA/BLA Number: NDA 22-154	NDA/BLA Approval: 4/28/2009

Tyzeka Tablets

Generic Name: telbivudine		Status: Approved
NDA/BLA Holder: Novartis	NDA/BLA Number: NDA 22-011/S-001	NDA/BLA Approval: 11/25/2006

Vimpat Injection

Generic Name: lacosamide		Status: Approved
NDA/BLA Holder: Schwarz Biosciences	NDA/BLA Number: NDA 22-253, 22-254	NDA/BLA Approval: 11/28/2008

Viramune Tablets and Oral Suspension

Generic Name: nevirapine		Status: Approved
NDA/BLA Holder: Boehringer Ingelheim	NDA/BLA Number: NDA 20-636/S-027	NDA/BLA Approval: 6/21/1996

Viramune Tablets and Oral Suspension

Generic Name: nevirapine		Status: Approved
NDA/BLA Holder: Boehringer Ingelheim	NDA/BLA Number: NDA 20-933/S-017	NDA/BLA Approval: 9/11/1998

Xenazine Tablets

Generic Name: tetrabenazine		Status: Approved
NDA/BLA Holder: Biovail Americas	NDA/BLA Number: NDA 21-894	NDA/BLA Approval: 8/15/2008

Xyrem

Generic Name: sodium oxybate		Status: Approved
NDA/BLA Holder: Jazz Pharmaceuticals	NDA/BLA Number: NDA 21-196	NDA/BLA Approval: 7/17/2002

Ziagen Tablets and Oral Solution

Generic Name: abacavir sulfate		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 20-977/S-017	NDA/BLA Approval: 12/17/1998

Ziagen Tablets and Oral Solution

Generic Name: abacavir sulfate		Status: Approved
NDA/BLA Holder: GlaxoSmithKline	NDA/BLA Number: NDA 20-978/S-020	NDA/BLA Approval: 12/17/1998

Zolpimist

Generic Name: zolpidem tartrate		Status: Approved
NDA/BLA Holder: Novadel	NDA/BLA Number: NDA 22-196	NDA/BLA Approval: 12/19/2008

Zonegran Capsules

Generic Name: zonisamide		Status: Approved
NDA/BLA Holder: Dainippon	NDA/BLA Number: NDA 20-789/S-022, S-025	NDA/BLA Approval: 3/27/2000

Zyprexa, Zyprexa Zydis Tablets

Generic Name: olanzapine		Status: Approved
NDA/BLA Holder: Eli Lilly	NDA/BLA Number: NDA 20-592/S-039	NDA/BLA Approval: 9/30/1996

Zyprexa, Zyprexa Zydis Tablets

Generic Name: olanzapine		Status: Approved
NDA/BLA Holder: Eli Lilly	NDA/BLA Number: NDA 21-086/S-021	NDA/BLA Approval: 4/6/2000

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