Details for New Drug Application (NDA): 204575
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NDA 204575 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 204575
| Tradename: | HYDROCODONE BITARTRATE AND IBUPROFEN |
| Applicant: | Aurolife Pharma Llc |
| Ingredient: | hydrocodone bitartrate; ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 204575
| Mechanism of Action | Cyclooxygenase Inhibitors Opioid Agonists |
Suppliers and Packaging for NDA: 204575
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 204575 | ANDA | Aurolife Pharma, LLC | 13107-004 | 13107-004-01 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-004-01) |
| HYDROCODONE BITARTRATE AND IBUPROFEN | hydrocodone bitartrate; ibuprofen | TABLET;ORAL | 204575 | ANDA | Aurolife Pharma, LLC | 13107-004 | 13107-004-05 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-004-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG;200MG | ||||
| Approval Date: | Jun 2, 2016 | TE: | AB | RLD: | No | ||||
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