Details for New Drug Application (NDA): 074329
NDA 074329 describes CIMETIDINE, which is a drug marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecules, Chartwell Rx, Contract Pharmacal, Cycle, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in fifty-one NDAs. It is available from seventeen suppliers. Additional details are available on the CIMETIDINE profile page.
The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.
Summary for 074329
| Tradename: | CIMETIDINE |
| Applicant: | Chartwell Molecules |
| Ingredient: | cimetidine |
| Patents: | 0 |
Pharmacology for NDA: 074329
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 074329
Suppliers and Packaging for NDA: 074329
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | cimetidine | TABLET;ORAL | 074329 | ANDA | Chartwell RX, LLC | 62135-630 | 62135-630-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62135-630-30) |
| CIMETIDINE | cimetidine | TABLET;ORAL | 074329 | ANDA | Chartwell RX, LLC | 62135-631 | 62135-631-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-631-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 800MG | ||||
| Approval Date: | May 17, 1994 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | May 17, 1994 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | May 17, 1994 | TE: | AB | RLD: | No | ||||
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