Details for New Drug Application (NDA): 204491
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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 204491
Tradename: | RALOXIFENE HYDROCHLORIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | raloxifene hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204491
Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 204491
Suppliers and Packaging for NDA: 204491
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 204491 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-393 | 68462-393-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-393-01) |
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 204491 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-393 | 68462-393-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-393-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Mar 22, 2016 | TE: | AB | RLD: | No |
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