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Details for New Drug Application (NDA): 077015
NDA 077015 describes SULFACETAMIDE SODIUM, which is a drug marketed by Fougera Pharms, Perrigo Co Tennessee, Taro, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Pharmafair, and Sandoz Inc, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the SULFACETAMIDE SODIUM profile page.
The generic ingredient in SULFACETAMIDE SODIUM is prednisolone sodium phosphate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate; sulfacetamide sodium profile page.
The generic ingredient in SULFACETAMIDE SODIUM is prednisolone sodium phosphate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate; sulfacetamide sodium profile page.
Summary for 077015
| Tradename: | SULFACETAMIDE SODIUM |
| Applicant: | Fougera Pharms |
| Ingredient: | sulfacetamide sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077015
| Ingredient-type | Sulfonamides |
Medical Subject Heading (MeSH) Categories for 077015
Suppliers and Packaging for NDA: 077015
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM | sulfacetamide sodium | LOTION;TOPICAL | 077015 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0382 | 0168-0382-04 | 118 mL in 1 BOTTLE (0168-0382-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 10% | ||||
| Approval Date: | Nov 17, 2006 | TE: | AB | RLD: | No | ||||
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