Details for New Drug Application (NDA): 208206
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NDA 208206 describes RALOXIFENE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Glenmark Pharms Ltd, Invagen Pharms, Sciegen Pharms Inc, Teva Pharms Usa, and Watson Labs Inc, and is included in eight NDAs. It is available from seventeen suppliers. Additional details are available on the RALOXIFENE HYDROCHLORIDE profile page.
The generic ingredient in RALOXIFENE HYDROCHLORIDE is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.
The generic ingredient in RALOXIFENE HYDROCHLORIDE is raloxifene hydrochloride. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the raloxifene hydrochloride profile page.
Summary for 208206
| Tradename: | RALOXIFENE HYDROCHLORIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | raloxifene hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208206
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 208206
Suppliers and Packaging for NDA: 208206
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 208206 | ANDA | AvPAK | 50268-694 | 50268-694-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-694-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-694-11) |
| RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 208206 | ANDA | Amneal Pharmaceuticals LLC | 65162-057 | 65162-057-03 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-057-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Apr 8, 2016 | TE: | AB | RLD: | No | ||||
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