Details for New Drug Application (NDA): 208315
✉ Email this page to a colleague
NDA 208315 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 208315
| Tradename: | MYCOPHENOLIC SODIUM |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | mycophenolic sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208315
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 208315 | ANDA | A-S Medication Solutions | 50090-6492 | 50090-6492-0 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6492-0) |
| MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 208315 | ANDA | Ascend Laboratories, LLC | 67877-426 | 67877-426-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 180MG BASE | ||||
| Approval Date: | Sep 23, 2021 | 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: | Sep 23, 2021 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
