Details for New Drug Application (NDA): 216482
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The generic ingredient in MYHIBBIN is mycophenolate mofetil. There are thirty-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil profile page.
Summary for 216482
Tradename: | MYHIBBIN |
Applicant: | Azurity |
Ingredient: | mycophenolate mofetil |
Patents: | 3 |
Suppliers and Packaging for NDA: 216482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MYHIBBIN | mycophenolate mofetil | SUSPENSION;ORAL | 216482 | NDA | Azurity Pharmaceuticals, Inc. | 24338-018 | 24338-018-01 | 1 BOTTLE, PLASTIC in 1 CARTON (24338-018-01) / 175 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 200MG/ML | ||||
Approval Date: | May 1, 2024 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | PROPHYLAXIS OF ORGAN REJECTION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | PROPHYLAXIS OF ORGAN REJECTION |
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