Details for New Drug Application (NDA): 215924
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NDA 215924 describes ORMALVI, which is a drug marketed by Torrent and is included in one NDA. It is available from two suppliers. Additional details are available on the ORMALVI profile page.
The generic ingredient in ORMALVI is dichlorphenamide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
The generic ingredient in ORMALVI is dichlorphenamide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dichlorphenamide profile page.
Summary for 215924
| Tradename: | ORMALVI |
| Applicant: | Torrent |
| Ingredient: | dichlorphenamide |
| Patents: | 0 |
Pharmacology for NDA: 215924
| Mechanism of Action | Carbonic Anhydrase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215924
Suppliers and Packaging for NDA: 215924
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORMALVI | dichlorphenamide | TABLET;ORAL | 215924 | ANDA | Torrent pharmaceuticals limited | 13668-676 | 13668-676-01 | 100 TABLET in 1 BOTTLE (13668-676-01) |
| ORMALVI | dichlorphenamide | TABLET;ORAL | 215924 | ANDA | Torrent pharmaceuticals limited | 13668-676 | 13668-676-30 | 30 TABLET in 1 BOTTLE (13668-676-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 29, 2022 | TE: | AB | RLD: | No | ||||
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