Details for New Drug Application (NDA): 214682
NDA 214682 describes FULVESTRANT, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Apotex, 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 sixteen 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 is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
The generic ingredient in FULVESTRANT is fulvestrant. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 214682
| Tradename: | FULVESTRANT |
| Applicant: | Jiangsu Hansoh Pharm |
| Ingredient: | fulvestrant |
| Patents: | 0 |
Pharmacology for NDA: 214682
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 214682
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 214682 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9022 | 0143-9022-02 | 2 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
| Approval Date: | Feb 10, 2022 | TE: | AO | RLD: | No | ||||
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