Details for New Drug Application (NDA): 091619
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NDA 091619 describes DISULFIRAM, which is a drug marketed by Alvogen, Chartwell Molecules, Dash Pharms, Hikma, Sigmapharm Labs Llc, Strides Pharma, Watson Labs, and Watson Labs Teva, and is included in eleven NDAs. It is available from four suppliers. Additional details are available on the DISULFIRAM profile page.
The generic ingredient in DISULFIRAM is disulfiram. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the disulfiram profile page.
The generic ingredient in DISULFIRAM is disulfiram. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the disulfiram profile page.
Summary for 091619
| Tradename: | DISULFIRAM |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | disulfiram |
| Patents: | 0 |
Pharmacology for NDA: 091619
| Mechanism of Action | Acetyl Aldehyde Dehydrogenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091619
Suppliers and Packaging for NDA: 091619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DISULFIRAM | disulfiram | TABLET;ORAL | 091619 | ANDA | Sigmapharm Laboratories, LLC | 42794-028 | 42794-028-08 | 30 TABLET in 1 BOTTLE (42794-028-08) |
| DISULFIRAM | disulfiram | TABLET;ORAL | 091619 | ANDA | Sigmapharm Laboratories, LLC | 42794-029 | 42794-029-08 | 30 TABLET in 1 BOTTLE (42794-029-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Mar 28, 2011 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 28, 2011 | TE: | AB | RLD: | No | ||||
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