Details for New Drug Application (NDA): 091633
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NDA 091633 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 091633
| Tradename: | HYDROCODONE BITARTRATE AND IBUPROFEN |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | hydrocodone bitartrate; ibuprofen |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;200MG | ||||
| Approval Date: | May 28, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG;200MG | ||||
| Approval Date: | May 28, 2013 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 7.5MG;200MG | ||||
| Approval Date: | May 28, 2013 | TE: | RLD: | No | |||||
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