Details for New Drug Application (NDA): 211689
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NDA 211689 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 Inc, Hbt Labs Inc, Jiangsu Hansoh Pharm, Sagent Pharms Inc, Sandoz, Teva Pharms Usa Inc, 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 211689
| Tradename: | FULVESTRANT |
| Applicant: | Accord Hlthcare |
| Ingredient: | fulvestrant |
| Patents: | 0 |
Pharmacology for NDA: 211689
| Mechanism of Action | Estrogen Receptor Antagonists Selective Estrogen Receptor Modulators |
Suppliers and Packaging for NDA: 211689
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 211689 | ANDA | Accord Healthcare Inc. | 16729-436 | 16729-436-30 | 2 SYRINGE, GLASS in 1 CARTON (16729-436-30) / 5 mL in 1 SYRINGE, GLASS (16729-436-31) |
| FULVESTRANT | fulvestrant | SOLUTION;INTRAMUSCULAR | 211689 | ANDA | BluePoint Laboratories | 68001-522 | 68001-522-85 | 2 SYRINGE, GLASS in 1 CARTON (68001-522-85) / 5 mL in 1 SYRINGE, GLASS (68001-522-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR | Strength | 250MG/5ML (50MG/ML) | ||||
| Approval Date: | Nov 17, 2020 | TE: | AO | RLD: | No | ||||
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