Details for New Drug Application (NDA): 216390
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NDA 216390 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.
The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE 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 HYDROCHLORIDE 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 216390
| Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
| Applicant: | Steriscience Speclts |
| Ingredient: | mycophenolate mofetil hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 216390 | ANDA | ARMAS PHARMACEUTICALS INC | 72485-415 | 72485-415-04 | 4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL |
| MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 216390 | ANDA | ONESOURCE SPECIALTY PHARMA LIMITED | 83270-000 | 83270-000-04 | 4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
| Approval Date: | Dec 23, 2022 | TE: | AP | RLD: | No | ||||
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