Details for New Drug Application (NDA): 203658
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NDA 203658 describes FAMOTIDINE; IBUPROFEN, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the FAMOTIDINE; IBUPROFEN profile page.
The generic ingredient in FAMOTIDINE; IBUPROFEN 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 FAMOTIDINE; IBUPROFEN 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 203658
| Tradename: | FAMOTIDINE; IBUPROFEN |
| Applicant: | Endo Operations |
| Ingredient: | famotidine; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 203658
| Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203658
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FAMOTIDINE; IBUPROFEN | famotidine; ibuprofen | TABLET;ORAL | 203658 | ANDA | ENDO USA, Inc. | 49884-366 | 49884-366-09 | 90 TABLET in 1 BOTTLE (49884-366-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 26.6MG;800MG | ||||
| Approval Date: | Mar 22, 2024 | TE: | AB | RLD: | No | ||||
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