Details for New Drug Application (NDA): 019525
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The generic ingredient in FML-S is fluorometholone; sulfacetamide sodium. There are five drug master file entries for this compound. Additional details are available on the fluorometholone; sulfacetamide sodium profile page.
Summary for 019525
| Tradename: | FML-S |
| Applicant: | Allergan |
| Ingredient: | fluorometholone; sulfacetamide sodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1%;10% | ||||
| Approval Date: | Sep 29, 1989 | TE: | RLD: | No | |||||
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