Details for New Drug Application (NDA): 216318
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NDA 216318 describes AZMIRO, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the AZMIRO profile page.
The generic ingredient in AZMIRO is testosterone cypionate. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone cypionate profile page.
The generic ingredient in AZMIRO is testosterone cypionate. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone cypionate profile page.
Summary for 216318
| Tradename: | AZMIRO |
| Applicant: | Azurity |
| Ingredient: | testosterone cypionate |
| Patents: | 2 |
Pharmacology for NDA: 216318
| Mechanism of Action | Androgen Receptor Agonists |
Suppliers and Packaging for NDA: 216318
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZMIRO | testosterone cypionate | SOLUTION;INTRAMUSCULAR | 216318 | NDA | Azurity Pharmaceuticals, Inc. | 24338-055 | 24338-055-01 | 1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS |
| AZMIRO | testosterone cypionate | SOLUTION;INTRAMUSCULAR | 216318 | NDA | Azurity Pharmaceuticals, Inc. | 24338-056 | 24338-056-01 | 1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 200MG/ML (200MG/ML) | ||||
| Approval Date: | Jun 2, 2022 | TE: | RLD: | Yes | |||||
| Patent: | 11,311,554 | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,642,355 | Patent Expiration: | Mar 25, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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