Active ingredient
Tropicamide
10 finished FDA listings contain Tropicamide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TROPICAMIDE
- Dosage forms
- Solution/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 5
- Strengths listed
- 10 mg/ml · 5 mg/ml
- Brand names in FDA listings
- Mydriacyl
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10869
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 084306 | ALCON LABS INC | 1974-12-06 | 3 |
| ANDA 084305 | SANDOZ | 1974-12-06 | 1 |
| ANDA 040064 | BAUSCH AND LOMB | 1994-07-27 | 2 |
| ANDA 040067 | BAUSCH AND LOMB | 1994-07-27 | 2 |
| ANDA 207524 | SOMERSET THERAPS LLC | 2019-12-12 | 2 |
Official labeling on DailyMed
- TROPICAMIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] · version 9 · 2026-05-13
- TROPICAMIDE SOLUTION/ DROPS [SPORTPHARM LLC] · version 2 · 2026-02-09
- TROPICAMIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 9 · 2023-10-27
- MYDRIACYL (TROPICAMIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] · version 9 · 2023-02-17
- MYDRIACYL (TROPICAMIDE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] · version 11 · 2022-12-26
- TROPICAMIDE SOLUTION/ DROPS [SANDOZ INC] · version 5 · 2022-07-04
- TROPICAMIDE SOLUTION/ DROPS [SANDOZ INC] · version 9 · 2022-03-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.