| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Chloraprep One-Step | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Frepp | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Sepp | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep Single Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep Triple Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab; Topical | Cardinal Hlth | Labeling Revision |
| Chloraprep With Tint | chlorhexidine gluconate; isopropyl alcohol | Sponge; Topical | Carefusion | Labeling Revision |
| Entacapone | entacapone | Tablet; Oral | Wockhardt Ltd | Approval |
| Strattera | atomoxetine hydrochloride | Capsule; Oral | Lilly | Labeling Revision |
| Tamiflu | oseltamivir phosphate | Capsule; Oral | Roche | Labeling Revision |
| Tamiflu | oseltamivir phosphate | For Suspension; Oral | Roche | Labeling Revision |
| Ultane | sevoflurane | Liquid; Inhalation | Abbott | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Tablet; Oral | Gilead Sciences Inc | Labeling Revision |
| Viread | tenofovir disoproxil fumarate | Powder; Oral | Gilead Sciences Inc | Labeling Revision |
