Details for New Drug Application (NDA): 077454
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NDA 077454 describes HYDROCODONE BITARTRATE AND IBUPROFEN, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Nostrum Labs Inc, Sun Pharm Inds Inc, and Teva, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the HYDROCODONE BITARTRATE AND IBUPROFEN profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND IBUPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
The generic ingredient in HYDROCODONE BITARTRATE AND IBUPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.
Summary for 077454
| Tradename: | HYDROCODONE BITARTRATE AND IBUPROFEN |
| Applicant: | Ani Pharms |
| Ingredient: | hydrocodone bitartrate; ibuprofen |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;200MG | ||||
| Approval Date: | Jun 23, 2010 | TE: | RLD: | No | |||||
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