Details for New Drug Application (NDA): 078558
NDA 078558 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Onesource, P And L Dev Llc, Patheon Softgels, Pharmazone, Sofgen Pharms, Guardian Drug, L Perrigo Co, Strides Pharma, Sun Pharma Canada, Tris Pharma Inc, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, Rubicon Research, Perrigo, Abbott, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Ph Health, Pliva, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Strides Pharma Intl, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, Pld Acquisitions Llc, Teva Pharms Usa, Torrent, Zydus Lifesciences, and Xgen Pharms, and is included in one hundred and eighty-four NDAs. It is available from two hundred and forty-four suppliers. Additional details are available on the IBUPROFEN profile page.
The generic ingredient in IBUPROFEN is ibuprofen sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen sodium profile page.
The generic ingredient in IBUPROFEN is ibuprofen sodium. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen sodium profile page.
Summary for 078558
| Tradename: | IBUPROFEN |
| Applicant: | Amneal Pharms Ny |
| Ingredient: | ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 078558
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 078558
Suppliers and Packaging for NDA: 078558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | ibuprofen | TABLET;ORAL | 078558 | ANDA | A-S Medication Solutions | 50090-6616 | 50090-6616-0 | 90 TABLET in 1 BOTTLE (50090-6616-0) |
| IBUPROFEN | ibuprofen | TABLET;ORAL | 078558 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-464 | 53746-464-01 | 100 TABLET in 1 BOTTLE (53746-464-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Jun 18, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jun 18, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Jun 18, 2007 | TE: | AB | RLD: | No | ||||
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