Details for New Drug Application (NDA): 218311
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NDA 218311 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 218311
| Tradename: | ACETAMINOPHEN AND IBUPROFEN |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 218311
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 218311
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 218311 | ANDA | GLENMARK THERAPEUTICS INC., USA | 72657-157 | 72657-157-05 | 1 BOTTLE in 1 CARTON (72657-157-05) / 500 TABLET, FILM COATED in 1 BOTTLE |
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 218311 | ANDA | GLENMARK THERAPEUTICS INC., USA | 72657-157 | 72657-157-18 | 1 BOTTLE in 1 CARTON (72657-157-18) / 18 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
| Approval Date: | Apr 26, 2024 | TE: | RLD: | No | |||||
| Regulatory Exclusivity Expiration: | Nov 3, 2024 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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