Details for New Drug Application (NDA): 206384
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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 206384
Tradename: | RALOXIFENE HYDROCHLORIDE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | raloxifene hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 206384
Mechanism of Action | Selective Estrogen Receptor Modulators |
Medical Subject Heading (MeSH) Categories for 206384
Suppliers and Packaging for NDA: 206384
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 206384 | ANDA | Major Pharmaceuticals | 0904-6902 | 0904-6902-04 | 30 BLISTER PACK in 1 CARTON (0904-6902-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
RALOXIFENE HYDROCHLORIDE | raloxifene hydrochloride | TABLET;ORAL | 206384 | ANDA | Dr.Reddy?s Laboratories Inc | 43598-505 | 43598-505-01 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-505-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Oct 12, 2016 | TE: | AB | RLD: | No |
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