Details for New Drug Application (NDA): 210326
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NDA 210326 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, Avyxa Holdings, Chia Tai Tianqing, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Glenmark Pharms, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty suppliers. There are three patents protecting this drug. Additional details are available on the FULVESTRANT profile page.
The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
The generic ingredient in FULVESTRANT is fulvestrant. There are twelve drug master file entries for this compound. Twenty-one 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: | ⤷ Start Trial | 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: | ⤷ Start Trial | 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: | ⤷ Start Trial | 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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