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Details for New Drug Application (NDA): 071265
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NDA 071265 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Sofgen Pharms, Strides Pharma, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Actavis Mid Atlantic, Aptapharma Inc, Arise, Hi Tech, P And L, Taro, Perrigo, Abbott, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules India, Granules India Ltd, Halsey, Hec Pharm, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Pliva, Purepac Pharm, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Vintage Pharms, Watson Labs, Dr Reddys Labs Ltd, and X-gen Pharms Inc, and is included in one hundred and sixty-one NDAs. It is available from two hundred and forty-three suppliers. Additional details are available on the IBUPROFEN profile page.
The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.
The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.
Summary for 071265
| Tradename: | IBUPROFEN |
| Applicant: | Contract Pharmacal |
| Ingredient: | ibuprofen |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 071265
Suppliers and Packaging for NDA: 071265
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | ibuprofen | TABLET;ORAL | 071265 | ANDA | Contract Pharmacal Corp. | 10267-3846 | 10267-3846-2 | 250 TABLET in 1 BOTTLE (10267-3846-2) |
| IBUPROFEN | ibuprofen | TABLET;ORAL | 071265 | ANDA | Contract Pharmacal Corp. | 10267-3852 | 10267-3852-2 | 250 TABLET in 1 BOTTLE (10267-3852-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Oct 15, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 10, 1987 | TE: | RLD: | No | |||||
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