DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 206531
NDA 206531 describes FAMOTIDINE, which is a drug marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Wockhardt Ltd, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and twelve suppliers. Additional details are available on the FAMOTIDINE profile page.
The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and seventy-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and seventy-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 206531
| Tradename: | FAMOTIDINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | famotidine |
| Patents: | 0 |
| Therapeutic Class: | Gastrointestinal Agents |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 206531
Suppliers and Packaging for NDA: 206531
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE | famotidine | TABLET;ORAL | 206531 | ANDA | Wal-Mart Stores, Inc. | 49035-505 | N | 49035-505-35 |
| FAMOTIDINE | famotidine | TABLET;ORAL | 206531 | ANDA | Magno-Humphries, Inc. | 54257-180 | N | 54257-180-07 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 26, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 26, 2016 | TE: | RLD: | No | |||||
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