Details for New Drug Application (NDA): 216814
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The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Twelve 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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