Details for New Drug Application (NDA): 078649
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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 078649
Tradename: | SULFACETAMIDE SODIUM |
Applicant: | Padagis Us |
Ingredient: | sulfacetamide sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 078649
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFACETAMIDE SODIUM | sulfacetamide sodium | LOTION;TOPICAL | 078649 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-896 | 45802-896-26 | 118 mL in 1 BOTTLE, PLASTIC (45802-896-26) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | 10% | ||||
Approval Date: | Mar 23, 2009 | TE: | AB | RLD: | No |
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