Details for New Drug Application (NDA): 207095
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NDA 207095 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, Onesource Specialty, P And L Dev Llc, Patheon Softgels, 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, Perrigo, Abbott, Adaptis, 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, Pharmobedient, 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 Pharms, and Xgen Pharms, and is included in one hundred and eighty-three NDAs. It is available from two hundred and thirty-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. 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 sixty-four 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 207095
| Tradename: | IBUPROFEN |
| Applicant: | Shandong Xinhua |
| Ingredient: | ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 207095
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 207095
Suppliers and Packaging for NDA: 207095
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | ibuprofen | TABLET;ORAL | 207095 | ANDA | PROSTAT FIRST AID | 58228-6185 | 58228-6185-1 | 10000 PACKET in 1 BAG (58228-6185-1) / 2 TABLET in 1 PACKET |
| IBUPROFEN | ibuprofen | TABLET;ORAL | 207095 | ANDA | Allegiant Health | 69168-466 | 69168-466-05 | 500 TABLET, FILM COATED in 1 BOTTLE (69168-466-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 5, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 21, 2018 | TE: | RLD: | No | |||||
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