Details for New Drug Application (NDA): 065413
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NDA 065413 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in forty-eight NDAs. It is available from twenty-nine suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 065413
| Tradename: | MYCOPHENOLATE MOFETIL |
| Applicant: | Hikma |
| Ingredient: | mycophenolate mofetil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065413
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 065413 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0166 | 0054-0166-25 | 100 TABLET in 1 BOTTLE (0054-0166-25) |
| MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 065413 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0166 | 0054-0166-29 | 500 TABLET in 1 BOTTLE (0054-0166-29) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 29, 2008 | TE: | AB | RLD: | No | ||||
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