Details for New Drug Application (NDA): 216592
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NDA 216592 describes ACETAMINOPHEN AND IBUPROFEN, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, Marksans Pharma, and Strides Pharma, and is included in eight NDAs. It is available from thirty-seven 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. Forty-two 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. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 216592
| Tradename: | ACETAMINOPHEN AND IBUPROFEN |
| Applicant: | Granules |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 216592
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 216592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 216592 | ANDA | WALGREENS | 0363-9131 | 0363-9131-16 | 216 TABLET in 1 BOTTLE (0363-9131-16) |
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 216592 | ANDA | WALGREENS | 0363-9131 | 0363-9131-44 | 144 TABLET in 1 BOTTLE (0363-9131-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
| Approval Date: | Jul 13, 2023 | TE: | RLD: | No | |||||
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