Details for New Drug Application (NDA): 215318
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NDA 215318 describes IBUPROFEN, which is a drug marketed by Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Strides Pharma, Guardian Drug, L Perrigo Co, Taro, 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 La, Dr Reddys Labs Inc, Endo Operations, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Northstar Hlthcare, Norvium Bioscience, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Pliva, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Dr Reddys Labs Ltd, Pld Acquisitions Llc, Teva Pharms Usa, and Xgen Pharms, and is included in one hundred and seventy-eight 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 215318
| Tradename: | IBUPROFEN |
| Applicant: | Yichang Humanwell |
| Ingredient: | ibuprofen |
| Patents: | 0 |
Pharmacology for NDA: 215318
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215318
Suppliers and Packaging for NDA: 215318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IBUPROFEN | ibuprofen | TABLET;ORAL | 215318 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-180 | 70436-180-01 | 100 TABLET in 1 BOTTLE (70436-180-01) |
| IBUPROFEN | ibuprofen | TABLET;ORAL | 215318 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-180 | 70436-180-02 | 500 TABLET in 1 BOTTLE (70436-180-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Mar 30, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Mar 30, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | Mar 30, 2022 | TE: | AB | RLD: | No | ||||
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