Details for New Drug Application (NDA): 089560
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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 089560
Tradename: | SULFACETAMIDE SODIUM |
Applicant: | Sandoz |
Ingredient: | sulfacetamide sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 089560
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SULFACETAMIDE SODIUM | sulfacetamide sodium | SOLUTION/DROPS;OPHTHALMIC | 089560 | ANDA | Sandoz Inc. | 61314-701 | 61314-701-01 | 15 mL in 1 BOTTLE, PLASTIC (61314-701-01) |
SULFACETAMIDE SODIUM | sulfacetamide sodium | SOLUTION/DROPS;OPHTHALMIC | 089560 | ANDA | Asclemed USA, Inc. | 76420-076 | 76420-076-15 | 15 mL in 1 BOTTLE, PLASTIC (76420-076-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 10% | ||||
Approval Date: | Oct 18, 1988 | TE: | AT | RLD: | No |
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