Details for New Drug Application (NDA): 211890
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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 211890
Tradename: | IBUPROFEN AND FAMOTIDINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | famotidine; ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 211890
Mechanism of Action | Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 211890
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890 | ANDA | Bryant Ranch Prepack | 63629-8891 | 63629-8891-1 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8891-1) |
IBUPROFEN AND FAMOTIDINE | famotidine; ibuprofen | TABLET;ORAL | 211890 | ANDA | Bryant Ranch Prepack | 63629-8891 | 63629-8891-2 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8891-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 26.6MG;800MG | ||||
Approval Date: | Aug 3, 2021 | TE: | AB | RLD: | No |
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