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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078542

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NDA 078542 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ranbaxy, Wockhardt, Apotex Inc, Bio Pharm Inc, Pharm Assoc, Dr Reddys Labs Inc, Amneal Pharms, Strides Pharma, Watson Labs, Sandoz, Aurobindo Pharma Ltd, Mylan, Actavis Mid Atlantic, Amneal Pharms Ny, Watson Labs Inc, Perrigo R And D, Sun Pharm Inds Ltd, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Tolmar, Teva, West-ward Pharms Int, Boehringer Ingelheim, Bedford, Ivax Sub Teva Pharms, Mylan Labs Ltd, Taro, Hi Tech Pharma, Apotex, Par Pharm, Breckenridge Pharm, Silarx, Vintage Pharms, Nostrum Labs Inc, Contract Pharmacal, and Perrigo, and is included in sixty-one NDAs. It is available from one hundred and thirty-three suppliers. Additional details are available on the RANITIDINE HYDROCHLORIDE profile page.

The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. One hundred and forty-one suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

Summary for NDA: 078542

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

Pharmacology for NDA: 078542

Suppliers and Packaging for NDA: 078542

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL 078542 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8021 0615-8021-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8021-05)
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride
TABLET;ORAL 078542 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8021 0615-8021-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8021-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Nov 19, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Nov 19, 2008TE:ABRLD:No


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Dow

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