Details for New Drug Application (NDA): 210063
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NDA 210063 describes CLIGAVYX, which is a drug marketed by Avyxa Holdings and is included in one NDA. It is available from one supplier. Additional details are available on the CLIGAVYX profile page.
The generic ingredient in CLIGAVYX is fulvestrant. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
The generic ingredient in CLIGAVYX is fulvestrant. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 210063
| Tradename: | CLIGAVYX |
| Applicant: | Avyxa Holdings |
| Ingredient: | fulvestrant |
| Patents: | 0 |
Pharmacology for NDA: 210063
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 210063
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLIGAVYX | fulvestrant | SOLUTION;INTRAMUSCULAR | 210063 | NDA | Avyxa Pharma, LLC | 83831-159 | 83831-159-02 | 2 SYRINGE, GLASS in 1 CARTON (83831-159-02) / 5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
| Approval Date: | Aug 19, 2019 | TE: | RLD: | No | |||||
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