FDA Orange Book · active-ingredient family
Atropine sulfate
Atropine sulfate is approved as 7 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ATROPINE SULFATE · NDA 213581
7
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, solution, solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATROPINE SULFATERLD | BAUSCH AND LOMB INC | NDA 213581 | — | Mar 15, 2022 | |
| ATROPINE SULFATERLD×2 | ACCORD HLTHCARE | NDA 214652 | — | Sep 29, 2020 | |
| ATROPINE SULFATERLD | FRESENIUS KABI USA | NDA 209260 | AP | Jan 26, 2018 | |
| ISOPTO ATROPINERLD | ALCON LABS INC | NDA 208151 | AT2 | Dec 01, 2016 | |
| ATROPINE SULFATERLD | RISING | NDA 206289 | AT1 | Jul 18, 2014 | |
| ATROPINE SULFATERLD×3 | HOSPIRA | NDA 021146 | AP | Jul 09, 2001 | |
| ATROPINE SULFATE | US ARMY | NDA 020056 | — | Sep 19, 1990 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATROPINE SULFATE | EDENBRIDGE PHARMS | ANDA 219013 | AT1 | Apr 15, 2026 | |
| ATROPINE SULFATE×2 | HIKMA | ANDA 217345 | AP | Oct 24, 2025 | |
| ATROPINE SULFATE | SOMERSET THERAPS LLC | ANDA 215005 | AP | Nov 29, 2024 | |
| ATROPINE SULFATE×2 | SOMERSET THERAPS LLC | ANDA 215969 | AP | Jul 03, 2024 | |
| ATROPINE SULFATE | SOMERSET THERAPS LLC | ANDA 215618 | AT1 | Jul 01, 2024 | |
| ATROPINE SULFATE | SOMERSET | ANDA 217791 | AT2 | Apr 29, 2024 | |
| ATROPINE SULFATE | MANKIND PHARMA | ANDA 218148 | AT1 | Jan 08, 2024 | |
| ATROPINE SULFATE | MEDEFIL INC | ANDA 214970 | AP | Nov 04, 2022 | |
| ATROPINE SULFATE | AMNEAL | ANDA 214752 | AT1 | Jul 14, 2022 | |
| ATROPINE SULFATE×2 | AM REGENT | ANDA 216120 | AP | May 26, 2022 | |
| ATROPINE SULFATE×2 | AMNEAL | ANDA 215342 | AP | Jan 26, 2022 | |
| ATROPINE SULFATE | HIKMA | ANDA 213561 | AP | Dec 01, 2021 | |
| ATROPINE SULFATE | APOTEX | ANDA 215624 | AT1 | Nov 26, 2021 | |
| ATROPINE SULFATE×3 | ACCORD HLTHCARE | ANDA 212868 | AP | Jul 26, 2021 | |
| ATROPINE SULFATE | ACCORD HLTHCARE | ANDA 213424 | AP | Mar 19, 2021 | |
| ATROPINE SULFATE | INTL MEDICATION SYS | ANDA 212461 | AP | Oct 05, 2020 |
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.
Atropine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
