Details for New Drug Application (NDA): 204310
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NDA 204310 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 204310
| Tradename: | RALOXIFENE HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | raloxifene hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204310
| Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 204310
Suppliers and Packaging for NDA: 204310
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 204310 | ANDA | NorthStar Rx LLC | 16714-213 | 16714-213-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-213-01) |
| RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 204310 | ANDA | NorthStar Rx LLC | 16714-213 | 16714-213-02 | 100 TABLET, FILM COATED in 1 BOTTLE (16714-213-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Aug 28, 2015 | TE: | AB | RLD: | No | ||||
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