Details for New Drug Application (NDA): 074553
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The generic ingredient in CIMETIDINE HYDROCHLORIDE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 074553
Tradename: | CIMETIDINE HYDROCHLORIDE |
Applicant: | Pharm Assoc |
Ingredient: | cimetidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074553
Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 074553
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074553 | ANDA | Pharmaceutical Associates, Inc. | 0121-0649 | 0121-0649-08 | 237 mL in 1 BOTTLE (0121-0649-08) |
CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074553 | ANDA | Pharmaceutical Associates, Inc. | 0121-0649 | 0121-0649-40 | 4 TRAY in 1 CASE (0121-0649-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0649-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 300MG BASE/5ML | ||||
Approval Date: | Jan 27, 1997 | TE: | RLD: | No |
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