Details for New Drug Application (NDA): 210044
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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 210044
Tradename: | FULVESTRANT |
Applicant: | Amneal |
Ingredient: | fulvestrant |
Patents: | 0 |
Pharmacology for NDA: 210044
Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 210044
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 210044 | ANDA | BluePoint Laboratories | 68001-484 | 68001-484-85 | 2 SYRINGE, GLASS in 1 CARTON (68001-484-85) / 5 mL in 1 SYRINGE, GLASS (68001-484-86) |
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 210044 | ANDA | Amneal Pharmaceuticals LLC | 70121-1463 | 70121-1463-2 | 2 SYRINGE, GLASS in 1 CARTON (70121-1463-2) / 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: | Mar 4, 2019 | TE: | AO | RLD: | No |
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