| Product NDC: | 65162-702 |
| Proprietary Name: | Fluocinolone Acetonide |
| Non Proprietary Name: | Fluocinolone Acetonide |
| Active Ingredient(s): | .11 mg/20mL & nbsp; Fluocinolone Acetonide |
| Administration Route(s): | AURICULAR (OTIC) |
| Dosage Form(s): | OIL |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65162-702 |
| Labeler Name: | Amneal Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA091306 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20111017 |
| Package NDC: | 65162-702-94 |
| Package Description: | 1 BOTTLE in 1 CARTON (65162-702-94) > 20 mL in 1 BOTTLE |
| NDC Code | 65162-702-94 |
| Proprietary Name | Fluocinolone Acetonide |
| Package Description | 1 BOTTLE in 1 CARTON (65162-702-94) > 20 mL in 1 BOTTLE |
| Product NDC | 65162-702 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Fluocinolone Acetonide |
| Dosage Form Name | OIL |
| Route Name | AURICULAR (OTIC) |
| Start Marketing Date | 20111017 |
| Marketing Category Name | ANDA |
| Labeler Name | Amneal Pharmaceuticals, LLC |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Strength Number | .11 |
| Strength Unit | mg/20mL |
| Pharmaceutical Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |