Details for New Drug Application (NDA): 216994
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NDA 216994 describes ACETAMINOPHEN AND IBUPROFEN, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, and Marksans Pharma, and is included in seven NDAs. It is available from thirty-four suppliers. Additional details are available on the ACETAMINOPHEN AND IBUPROFEN profile page.
The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 216994
| Tradename: | ACETAMINOPHEN AND IBUPROFEN |
| Applicant: | Marksans Pharma |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 216994
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 216994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 216994 | ANDA | TARGET CORPORATION | 11673-924 | 11673-924-75 | 1 BOTTLE in 1 CARTON (11673-924-75) / 72 TABLET in 1 BOTTLE |
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 216994 | ANDA | BETTER LIVING BRANDS, LLC | 21130-716 | 21130-716-08 | 1 BOTTLE in 1 CARTON (21130-716-08) / 18 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
| Approval Date: | Jul 10, 2023 | TE: | RLD: | No | |||||
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