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 are three patents 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. Six 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. Six 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: | 3 |
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 | |||||
| Regulatory Exclusivity Expiration: | Mar 25, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Sep 25, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | 10,058,536*PED | Patent Expiration: | Sep 30, 2036 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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