Details for New Drug Application (NDA): 209471
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NDA 209471 describes COMBOGESIC, which is a drug marketed by Aft Pharms Ltd and Hikma and is included in two NDAs. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the COMBOGESIC profile page.
The generic ingredient in COMBOGESIC is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.
The generic ingredient in COMBOGESIC is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.
Summary for 209471
| Tradename: | COMBOGESIC |
| Applicant: | Aft Pharms Ltd |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 3 |
Pharmacology for NDA: 209471
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 209471
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COMBOGESIC | acetaminophen; ibuprofen | TABLET;ORAL | 209471 | NDA | Hikma Pharmaceuticals USA Inc | 0143-9432 | 0143-9432-27 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0143-9432-27) |
| COMBOGESIC | acetaminophen; ibuprofen | TABLET;ORAL | 209471 | NDA | AFT Pharmaceuticals US, Inc. | 72260-129 | 72260-129-01 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72260-129-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 325MG;97.5MG | ||||
| Approval Date: | Mar 1, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 22, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 27, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION | ||||||||
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