Details for New Drug Application (NDA): 204473
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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 204473
Tradename: | MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | mycophenolate mofetil hydrochloride |
Patents: | 0 |
Suppliers and Packaging for NDA: 204473
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 204473 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-669 | 68382-669-08 | 4 VIAL in 1 CARTON (68382-669-08) / 20 mL in 1 VIAL |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 204473 | ANDA | Zydus Lifesciences Limited | 70771-1084 | 70771-1084-8 | 4 VIAL in 1 CARTON (70771-1084-8) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Aug 31, 2017 | TE: | AP | RLD: | No |
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