Details for New Drug Application (NDA): 216482
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NDA 216482 describes MYHIBBIN, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MYHIBBIN profile page.
The generic ingredient in MYHIBBIN is mycophenolate mofetil. There are thirty-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil profile page.
The generic ingredient in MYHIBBIN is mycophenolate mofetil. There are thirty-eight drug master file entries for this compound. Thirty-one 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: | 11,931,455 | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PROPHYLAXIS OF ORGAN REJECTION | ||||||||
| Patent: | 12,097,284 | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,097,285 | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PROPHYLAXIS OF ORGAN REJECTION | ||||||||
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