Details for New Drug Application (NDA): 078542
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NDA 078542 describes RANITIDINE HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Dr Reddys Labs Ltd, Norvium Bioscience, Novitium Pharma, Sandoz, Teva, Bedford, Hikma, Mylan Labs Ltd, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Apotex Inc, Epic Pharma Llc, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Ranbaxy, Taro, Tolmar, Torrent, Wockhardt, Amneal Pharms Ny, Ani Pharms, Apotex, Boehringer Ingelheim, Contract Pharmacal, Dr Reddys Labs Inc, Endo Operations, Glenmark Pharms Inc, Granules, Heritage Pharma Avet, Mylan, Perrigo, Perrigo R And D, Strides Pharma, Sun Pharm Inds Ltd, Thinq Pharm-cro Pvt, Vkt Pharma, Watson Labs, and Wockhardt Ltd, and is included in seventy-five NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. 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. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 078542
| Tradename: | RANITIDINE HYDROCHLORIDE |
| Applicant: | Glenmark Pharms Inc |
| Ingredient: | ranitidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078542
| Mechanism of Action | Histamine H2 Receptor Antagonists |
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 | Bryant Ranch Prepack | 71335-1327 | 71335-1327-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1327-1) |
| RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 078542 | ANDA | Bryant Ranch Prepack | 71335-1327 | 71335-1327-2 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1327-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Nov 19, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
| Approval Date: | Nov 19, 2008 | TE: | AB | RLD: | No | ||||
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