Details for New Drug Application (NDA): 218359
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NDA 218359 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-five 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 218359
| Tradename: | ACETAMINOPHEN AND IBUPROFEN |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | acetaminophen; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 218359
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 218359
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 218359 | ANDA | Aurohealth LLC | 58602-893 | 58602-893-01 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-893-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 218359 | ANDA | Aurohealth LLC | 58602-893 | 58602-893-03 | 1 BOTTLE in 1 CARTON (58602-893-03) / 10 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
| Approval Date: | Mar 26, 2024 | TE: | RLD: | No | |||||
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