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Julphar
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074463

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NDA 074463 describes CIMETIDINE, which is a drug marketed by Apotex, Chartwell Molecules, Contract Pharmacal, Cycle Pharms Ltd, Dava Pharms Inc, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Perrigo, Pliva, Sandoz, Sandoz Inc, Teva, Upsher-smith Labs, Watson Labs Inc, Watson Labs Teva, Hospira, Luitpold, Teva Parenteral, Vintage Pharms Llc, Ani Pharms Inc, Apotex Inc, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, and Wockhardt, and is included in fifty NDAs. It is available from twenty-six suppliers. Additional details are available on the CIMETIDINE profile page.

The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 074463

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074463

Suppliers and Packaging for NDA: 074463

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CIMETIDINE cimetidine TABLET;ORAL 074463 ANDA Teva Pharmaceuticals USA Inc 0093-8305 0093-8305-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-8305-01)
CIMETIDINE cimetidine TABLET;ORAL 074463 ANDA Bryant Ranch Prepack 63629-1495 63629-1495-2 60 TABLET, FILM COATED in 1 BOTTLE (63629-1495-2)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:May 17, 1994TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Teva
Baxter
Mallinckrodt
AstraZeneca
Cerilliant
McKesson
Citi
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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