Suppliers and packages for generic ingredient: famotidine; ibuprofen
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famotidine; ibuprofen
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519 | NDA AUTHORIZED GENERIC | Lupin Pharmaceuticals, Inc. | 70748-312-09 | 90 TABLET, COATED in 1 BOTTLE (70748-312-09) | 2021-09-14 |
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519 | NDA | Horizon Therapeutics USA, Inc. | 75987-010-03 | 90 TABLET, COATED in 1 BOTTLE (75987-010-03) | 2011-12-05 |
| Horizon | DUEXIS | famotidine; ibuprofen | TABLET;ORAL | 022519 | NDA | Horizon Therapeutics USA, Inc. | 75987-010-72 | 9 BLISTER PACK in 1 CARTON (75987-010-72) / 3 TABLET, COATED in 1 BLISTER PACK | 2011-12-05 |
| Endo Operations | FAMOTIDINE; IBUPROFEN | famotidine; ibuprofen | TABLET;ORAL | 203658 | ANDA | ENDO USA, Inc. | 49884-366-09 | 90 TABLET in 1 BOTTLE (49884-366-09) | 2024-03-22 |
| Alkem Labs Ltd | IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890 | ANDA | Bryant Ranch Prepack | 63629-8891-1 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8891-1) | 2021-08-04 |
| Alkem Labs Ltd | IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890 | ANDA | Bryant Ranch Prepack | 63629-8891-2 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8891-2) | 2021-08-04 |
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