Details for New Drug Application (NDA): 216814
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NDA 216814 describes IBUPROFEN AND FAMOTIDINE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the IBUPROFEN AND FAMOTIDINE profile page.
The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.
Summary for 216814
| Tradename: | IBUPROFEN AND FAMOTIDINE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | famotidine; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 216814
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 216814
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 216814 | ANDA | Camber Pharmaceuticals, Inc. | 31722-315 | 31722-315-90 | 90 TABLET in 1 BOTTLE (31722-315-90) |
| IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 216814 | ANDA | Ascent Pharmaceuticals, Inc. | 43602-544 | 43602-544-05 | 500 TABLET in 1 BOTTLE (43602-544-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 26.6MG;800MG | ||||
| Approval Date: | Mar 15, 2023 | TE: | AB | RLD: | No | ||||
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