Details for New Drug Application (NDA): 077405
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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 077405
Tradename: | RANITIDINE HYDROCHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | ranitidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077405
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 077405
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | SYRUP;ORAL | 077405 | ANDA | Pharmaceutical Associates, Inc. | 0121-0727 | 0121-0727-16 | 473 mL in 1 BOTTLE (0121-0727-16) |
RANITIDINE HYDROCHLORIDE | ranitidine hydrochloride | SYRUP;ORAL | 077405 | ANDA | Pharmaceutical Associates, Inc. | 0121-4727 | 0121-4727-10 | 4 TRAY in 1 CASE (0121-4727-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | EQ 15MG BASE/ML | ||||
Approval Date: | Sep 21, 2007 | TE: | AA | RLD: | No |
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