Details for New Drug Application (NDA): 209714
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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 209714
Tradename: | FULVESTRANT |
Applicant: | Hbt Labs Inc |
Ingredient: | fulvestrant |
Patents: | 0 |
Pharmacology for NDA: 209714
Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 209714
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 209714 | ANDA | Meitheal Pharmaceuticals Inc | 71288-555 | 71288-555-86 | 2 SYRINGE in 1 CARTON (71288-555-86) / 5 mL in 1 SYRINGE (71288-555-85) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
Approval Date: | Nov 21, 2019 | TE: | AO | RLD: | No |
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