Drug
Submitted on
Approved on
Time Spent (Month)
1 Jublia® (efinaconazole) topical solution, 10%.
22 June 2021
2 Perrigo’s Testosterone Topical Solution, 30mg/1.5mL
17 October 2018
12 January 2021
27
3 EMLA® (Lidocaine 2.5% and Prilocaine 2.5%) Cream
19 August 2019
28 July 2021
23
4 Dapsone Gel, 5%
13 September 2021
7 June 2023
21
5 Dapsone Gel, 7.5%.
15 April 2021
[2024?]
6 cold sore treatment, Acyclovir Cream, 5%
8 August 2022
[2024?]
7 Nitroglycerin Ointment, 0.4%
4 July 2023
[2025?]
Ann: Launch of Dapsone 5%, Gel in the United States, page-42
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