Details for New Drug Application (NDA): 074655
✉ Email this page to a colleague
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 074655
Tradename: | RANITIDINE HYDROCHLORIDE |
Applicant: | Sandoz |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074655
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 074655
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | CAPSULE;ORAL | 074655 | ANDA | Sandoz Inc | 0781-2855 | 0781-2855-05 | 500 CAPSULE in 1 BOTTLE (0781-2855-05) |
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | CAPSULE;ORAL | 074655 | ANDA | Sandoz Inc | 0781-2855 | 0781-2855-31 | 30 CAPSULE in 1 BOTTLE (0781-2855-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Oct 22, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 300MG BASE | ||||
Approval Date: | Oct 22, 1997 | TE: | AB | RLD: | No |
Complete Access Available with Subscription