Details for New Drug Application (NDA): 213801
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NDA 213801 describes MYRBETRIQ GRANULES, which is a drug marketed by Apgdi and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MYRBETRIQ GRANULES profile page.
The generic ingredient in MYRBETRIQ GRANULES is mirabegron. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
The generic ingredient in MYRBETRIQ GRANULES is mirabegron. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 213801
| Tradename: | MYRBETRIQ GRANULES |
| Applicant: | Apgdi |
| Ingredient: | mirabegron |
| Patents: | 1 |
Suppliers and Packaging for NDA: 213801
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYRBETRIQ GRANULES | mirabegron | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 213801 | NDA | Astellas Pharma US, Inc. | 0469-5020 | 0469-5020-99 | 1 BOTTLE in 1 CARTON (0469-5020-99) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;ORAL | Strength | 8MG/ML | ||||
| Approval Date: | Mar 25, 2021 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 30, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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