Details for New Drug Application (NDA): 074664
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NDA 074664 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Cosette, Endo Operations, Hospira, Luitpold, Teva Parenteral, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from two suppliers. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.
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.
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 074664
| Tradename: | CIMETIDINE HYDROCHLORIDE |
| Applicant: | Pai Holdings Pharm |
| Ingredient: | cimetidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 074664
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Suppliers and Packaging for NDA: 074664
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE HYDROCHLORIDE | cimetidine hydrochloride | SOLUTION;ORAL | 074664 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1025 | 0121-1025-08 | 237 mL in 1 BOTTLE (0121-1025-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 300MG BASE/5ML | ||||
| Approval Date: | Oct 28, 1997 | TE: | AA | RLD: | No | ||||
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