Details for New Drug Application (NDA): 210326
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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 210326
Tradename: | FULVESTRANT |
Applicant: | Fresenius Kabi Usa |
Ingredient: | fulvestrant |
Patents: | 3 |
Pharmacology for NDA: 210326
Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 210326
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 210326 | NDA | Fresenius Kabi USA, LLC | 63323-715 | 63323-715-05 | 2 SYRINGE, GLASS in 1 CARTON (63323-715-05) / 5 mL in 1 SYRINGE, GLASS (63323-715-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
Approval Date: | May 20, 2019 | TE: | AO | RLD: | No | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 14, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN |
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