Details for New Drug Application (NDA): 077824
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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 077824
Tradename: | RANITIDINE HYDROCHLORIDE |
Applicant: | Amneal Pharms Ny |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077824
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 077824
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 077824 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-445 | 43353-445-60 | 90 TABLET in 1 BOTTLE (43353-445-60) |
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | TABLET;ORAL | 077824 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-445 | 43353-445-80 | 180 TABLET in 1 BOTTLE (43353-445-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Oct 13, 2006 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Oct 13, 2006 | TE: | RLD: | No |
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