Details for New Drug Application (NDA): 215077
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NDA 215077 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 Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Xiromed, and Zydus Pharms, and is included in seventeen NDAs. It is available from nineteen 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 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 suppliers are listed for this compound. Additional details are available on the fulvestrant profile page.
Summary for 215077
| Tradename: | FULVESTRANT |
| Applicant: | Alembic |
| Ingredient: | fulvestrant |
| Patents: | 0 |
Pharmacology for NDA: 215077
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 215077
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 215077 | ANDA | Alembic Pharmaceuticals Inc. | 62332-650 | 62332-650-10 | 2 SYRINGE in 1 CARTON (62332-650-10) / 5 mL in 1 SYRINGE (62332-650-05) |
| FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 215077 | ANDA | BluePoint Laboratories. | 68001-626 | 68001-626-85 | 2 SYRINGE in 1 CARTON (68001-626-85) / 5 mL in 1 SYRINGE (68001-626-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
| Approval Date: | Dec 22, 2022 | TE: | AO | RLD: | No | ||||
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