Details for New Drug Application (NDA): 074449
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NDA 074449 describes SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, which is a drug marketed by Bausch And Lomb and Genus and is included in two NDAs. It is available from three suppliers. Additional details are available on the SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE profile page.
The generic ingredient in SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE 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 AND PREDNISOLONE SODIUM PHOSPHATE 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 074449
| Tradename: | SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE |
| Applicant: | Bausch And Lomb |
| Ingredient: | prednisolone sodium phosphate; sulfacetamide sodium |
| Patents: | 0 |
Pharmacology for NDA: 074449
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 074449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate; sulfacetamide sodium | SOLUTION/DROPS;OPHTHALMIC | 074449 | ANDA | Bausch & Lomb Incoporated | 24208-317 | 24208-317-05 | 1 BOTTLE, DROPPER in 1 CARTON (24208-317-05) / 5 mL in 1 BOTTLE, DROPPER |
| SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | prednisolone sodium phosphate; sulfacetamide sodium | SOLUTION/DROPS;OPHTHALMIC | 074449 | ANDA | Bausch & Lomb Incoporated | 24208-317 | 24208-317-10 | 1 BOTTLE, DROPPER in 1 CARTON (24208-317-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.23% PHOSPHATE;10% | ||||
| Approval Date: | Dec 29, 1995 | TE: | RLD: | No | |||||
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