Details for New Drug Application (NDA): 201745
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The generic ingredient in RANITIDINE HYDROCHLORIDE is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.
Summary for 201745
Tradename: | RANITIDINE HYDROCHLORIDE |
Applicant: | Strides Pharma |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201745
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 201745
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 201745 | ANDA | WinCo Foods, LLC | 67091-244 | 67091-244-30 | 1 BOTTLE in 1 CARTON (67091-244-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Feb 29, 2012 | TE: | RLD: | No |
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