Details for New Drug Application (NDA): 206505
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NDA 206505 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Trupharma, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-three NDAs. It is available from twenty-four suppliers. Additional details are available on the DAPSONE profile page.
The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.
The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 206505
| Tradename: | DAPSONE |
| Applicant: | Novitium Pharma |
| Ingredient: | dapsone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206505
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPSONE | dapsone | TABLET;ORAL | 206505 | ANDA | ANI Pharmaceuticals, Inc. | 70954-135 | 70954-135-10 | 30 TABLET in 1 BOTTLE (70954-135-10) |
| DAPSONE | dapsone | TABLET;ORAL | 206505 | ANDA | ANI Pharmaceuticals, Inc. | 70954-135 | 70954-135-20 | 100 TABLET in 1 BOTTLE (70954-135-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Dec 1, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 1, 2016 | TE: | AB | RLD: | No | ||||
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