Details for New Drug Application (NDA): 074890
NDA 074890 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 074890
| Tradename: | CIMETIDINE |
| Applicant: | Hikma |
| Ingredient: | cimetidine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 074890
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Dec 18, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Dec 18, 1998 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Dec 18, 1998 | TE: | RLD: | No | |||||
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