Details for New Drug Application (NDA): 218997
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NDA 218997 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, Cosette, 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 fourteen suppliers. Additional details are available on the CIMETIDINE profile page.
The generic ingredient in CIMETIDINE is cimetidine hydrochloride. There are twenty-five 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 twenty-five 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 218997
| Tradename: | CIMETIDINE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | cimetidine |
| Patents: | 0 |
Pharmacology for NDA: 218997
| Mechanism of Action | Histamine H2 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 218997
Suppliers and Packaging for NDA: 218997
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIMETIDINE | cimetidine | TABLET;ORAL | 218997 | ANDA | Aurobindo Pharma Limited | 59651-823 | 59651-823-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-823-01) |
| CIMETIDINE | cimetidine | TABLET;ORAL | 218997 | ANDA | Aurobindo Pharma Limited | 59651-824 | 59651-824-01 | 100 TABLET, FILM COATED in 1 BOTTLE (59651-824-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 12, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Nov 12, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG | ||||
| Approval Date: | Nov 12, 2024 | TE: | AB | RLD: | No | ||||
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