Details for New Drug Application (NDA): 211422
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The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 211422
Tradename: | FULVESTRANT |
Applicant: | Chia Tai Tianqing |
Ingredient: | fulvestrant |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211422
Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 211422
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 211422 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-211 | 70860-211-74 | 2 SYRINGE, GLASS in 1 CARTON (70860-211-74) / 5 mL in 1 SYRINGE, GLASS (70860-211-41) |
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 211422 | ANDA | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 71731-6121 | 71731-6121-1 | 2 SYRINGE, GLASS in 1 CARTON (71731-6121-1) / 5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
Approval Date: | Feb 7, 2020 | TE: | AO | RLD: | No |
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