Details for New Drug Application (NDA): 091558
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NDA 091558 describes MYCOPHENOLATE SODIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Fosun Wanbang, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the MYCOPHENOLATE SODIUM profile page.
The generic ingredient in MYCOPHENOLATE SODIUM is mycophenolate sodium. There are thirty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.
The generic ingredient in MYCOPHENOLATE SODIUM is mycophenolate sodium. There are thirty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.
Summary for 091558
| Tradename: | MYCOPHENOLATE SODIUM |
| Applicant: | Apotex Inc |
| Ingredient: | mycophenolate sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE SODIUM | mycophenolate sodium | TABLET, DELAYED RELEASE;ORAL | 091558 | ANDA | Major Pharmaceuticals | 0904-6785 | 0904-6785-04 | 30 BLISTER PACK in 1 CARTON (0904-6785-04) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
| MYCOPHENOLATE SODIUM | mycophenolate sodium | TABLET, DELAYED RELEASE;ORAL | 091558 | ANDA | Major Pharmaceuticals | 0904-6785 | 0904-6785-61 | 100 BLISTER PACK in 1 CARTON (0904-6785-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 180MG BASE | ||||
| Approval Date: | Aug 21, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 360MG BASE | ||||
| Approval Date: | Aug 19, 2014 | TE: | AB | RLD: | No | ||||
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