Details for New Drug Application (NDA): 080029
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NDA 080029 describes SULFACETAMIDE SODIUM, which is a drug marketed by Fougera Pharms, Padagis Us, Taro, Akorn, Alcon Pharms Ltd, Bausch And Lomb, Epic Pharma Llc, Pharmafair, and Sandoz, and is included in twelve NDAs. It is available from nine 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate; sulfacetamide sodium profile page.
Summary for 080029
| Tradename: | SULFACETAMIDE SODIUM |
| Applicant: | Padagis Us |
| Ingredient: | sulfacetamide sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 080029
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM | sulfacetamide sodium | OINTMENT;OPHTHALMIC | 080029 | ANDA | Padagis US LLC | 0574-4190 | 0574-4190-35 | 1 TUBE in 1 CARTON (0574-4190-35) / 3.5 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;OPHTHALMIC | Strength | 10% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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