Details for New Drug Application (NDA): 091534
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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 091534
Tradename: | RANITIDINE HYDROCHLORIDE |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091534
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 091534
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | INJECTABLE;INJECTION | 091534 | ANDA | Zydus Lifesciences Limited | 65841-763 | 65841-763-02 | 10 VIAL in 1 CARTON (65841-763-02) / 2 mL in 1 VIAL |
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | INJECTABLE;INJECTION | 091534 | ANDA | Zydus Lifesciences Limited | 65841-764 | 65841-764-06 | 6 mL in 1 VIAL, MULTI-DOSE (65841-764-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 25MG BASE/ML | ||||
Approval Date: | Feb 22, 2013 | TE: | RLD: | No |
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