Details for New Drug Application (NDA): 213955
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The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 213955
Tradename: | MYCOPHENOLATE MOFETIL |
Applicant: | Hetero Labs Ltd V |
Ingredient: | mycophenolate mofetil |
Patents: | 0 |
Suppliers and Packaging for NDA: 213955
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYCOPHENOLATE MOFETIL | mycophenolate mofetil | FOR SUSPENSION;ORAL | 213955 | ANDA | airis PHARMA Private Limited | 71151-025 | 71151-025-01 | 1 BOTTLE, PLASTIC in 1 CARTON (71151-025-01) / 225 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/ML | ||||
Approval Date: | Sep 11, 2023 | TE: | AB | RLD: | No |
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