Details for New Drug Application (NDA): 091558
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NDA 091558 describes MYCOPHENOLIC SODIUM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Wanbang Biopharms, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the MYCOPHENOLIC SODIUM profile page.
The generic ingredient in MYCOPHENOLIC SODIUM is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.
The generic ingredient in MYCOPHENOLIC SODIUM is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.
Summary for 091558
| Tradename: | MYCOPHENOLIC SODIUM |
| Applicant: | Apotex Inc |
| Ingredient: | mycophenolic sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091558
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | mycophenolic 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 |
| MYCOPHENOLIC SODIUM | mycophenolic 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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