| Product NDC: | 11980-228 |
| Proprietary Name: | FML FORTE |
| Non Proprietary Name: | fluorometholone |
| Active Ingredient(s): | 2.5 mg/mL & nbsp; fluorometholone |
| Administration Route(s): | OPHTHALMIC |
| Dosage Form(s): | SUSPENSION/ DROPS |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 11980-228 |
| Labeler Name: | Allergan, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019216 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19860501 |
| Package NDC: | 11980-228-05 |
| Package Description: | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) > 5 mL in 1 BOTTLE, DROPPER |
| NDC Code | 11980-228-05 |
| Proprietary Name | FML FORTE |
| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) > 5 mL in 1 BOTTLE, DROPPER |
| Product NDC | 11980-228 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | fluorometholone |
| Dosage Form Name | SUSPENSION/ DROPS |
| Route Name | OPHTHALMIC |
| Start Marketing Date | 19860501 |
| Marketing Category Name | NDA |
| Labeler Name | Allergan, Inc. |
| Substance Name | FLUOROMETHOLONE |
| Strength Number | 2.5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |