Details for New Drug Application (NDA): 078193
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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 078193
Tradename: | RALOXIFENE HYDROCHLORIDE |
Applicant: | Teva Pharms Usa |
Ingredient: | raloxifene hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078193
Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 078193
Suppliers and Packaging for NDA: 078193
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 078193 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7290 | 0093-7290-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-7290-01) |
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 078193 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7290 | 0093-7290-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7290-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Mar 4, 2014 | TE: | AB | RLD: | No |
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