FDA Orange Book · active-ingredient family
Tropicamide
Tropicamide is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MYDRIACYL · NDA 012111
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MYDRIACYL×2 | ALCON | NDA 012111 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TROPICAMIDE | SOMERSET THERAPS LLC | ANDA 207524 | AT | Dec 12, 2019 | |
| TROPICACYL | EPIC PHARMA LLC | ANDA 040314 | AT | Sep 29, 2000 | |
| TROPICACYL | RISING | ANDA 040315 | AT | Sep 29, 2000 | |
| TROPICAMIDE | BAUSCH AND LOMB | ANDA 040067 | AT | Jul 27, 1994 | |
| TROPICAMIDE | BAUSCH AND LOMB | ANDA 040064 | AT | Jul 27, 1994 | |
| TROPICAMIDE | ALCON PHARMS LTD | ANDA 089172 | — | Dec 28, 1990 | |
| TROPICAMIDE | WATSON LABS | ANDA 089171 | — | Dec 28, 1990 | |
| TROPICAMIDE | EPIC PHARMA LLC | ANDA 088447 | — | Aug 28, 1985 | |
| MYDRIAFAIR | PHARMAFAIR | ANDA 088274 | — | Sep 16, 1983 | |
| MYDRIAFAIR | PHARMAFAIR | ANDA 088230 | — | Sep 16, 1983 | |
| TROPICAMIDE | MIZA PHARMS USA | ANDA 087637 | — | Aug 09, 1982 | |
| TROPICAMIDE | MIZA PHARMS USA | ANDA 087636 | — | Jul 30, 1982 | |
| MYDRIACYLRLD | ALCON LABS INC | ANDA 084306 | AT | Approved Prior to Jan 1, 1982 | |
| MYDRIACYLRLD | SANDOZ | ANDA 084305 | AT | Approved Prior to Jan 1, 1982 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Tropicamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
