Details for New Drug Application (NDA): 214745
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NDA 214745 describes DIAZEPAM, which is a drug marketed by Chartwell Molecular, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hikma, Hospira, Long Grove Pharms, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, and Virtus, and is included in seventy-nine NDAs. It is available from forty-one suppliers. Additional details are available on the DIAZEPAM profile page.
The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.
The generic ingredient in DIAZEPAM is diazepam. There are eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.
Summary for 214745
| Tradename: | DIAZEPAM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | diazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214745
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIAZEPAM | diazepam | INJECTABLE;INJECTION | 214745 | ANDA | Fresenius Kabi USA, LLC | 76045-204 | 76045-204-20 | 24 SYRINGE, GLASS in 1 CARTON (76045-204-20) / 2 mL in 1 SYRINGE, GLASS (76045-204-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/2ML (5MG/ML) | ||||
| Approval Date: | Nov 10, 2022 | TE: | AP | RLD: | No | ||||
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