Details for New Drug Application (NDA): 216400
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NDA 216400 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, Upsher Smith Labs, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, MSN, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Torrent, Epic Pharma Llc, Abbvie, Baxter Hlthcare, and Endo Operations, and is included in eighty-six NDAs. It is available from one hundred and thirty-seven 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 eighty-two drug master file entries for this compound. Twenty-three 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 eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.
Summary for 216400
| Tradename: | FAMOTIDINE |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | famotidine |
| Patents: | 0 |
Pharmacology for NDA: 216400
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 216400
Suppliers and Packaging for NDA: 216400
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE | famotidine | FOR SUSPENSION;ORAL | 216400 | ANDA | Ascend Laboratories, LLC | 67877-775 | 67877-775-89 | 50 mL in 1 BOTTLE (67877-775-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 40MG/5ML | ||||
| Approval Date: | May 15, 2023 | TE: | AB | RLD: | No | ||||
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