Orange Book product · Generic (ANDA)
ATROPINE SULFATE
ATROPINE SULFATE
At a glance
Oct 24, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 24, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE
Strength
0.4MG/ML (0.4MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 217345
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ATROPINE SULFATE
- 2022ATROPINE SULFATEBrand (NDA)
NDA 213581 · BAUSCH AND LOMB INC
- 2020ATROPINE SULFATEBrand (NDA)
NDA 214652 · ACCORD HLTHCARE
- 2018ATROPINE SULFATEBrand (NDA)
NDA 209260 · FRESENIUS KABI USA
- 2016ISOPTO ATROPINEBrand (NDA)
NDA 208151 · ALCON LABS INC
- 2014ATROPINE SULFATEBrand (NDA)
NDA 206289 · RISING
- 2001ATROPINE SULFATEBrand (NDA)
NDA 021146 · HOSPIRA
- 1990ATROPINE SULFATEBrand (NDA)
NDA 020056 · US ARMY
- 2026ATROPINE SULFATEGeneric (ANDA)
ANDA 219013 · EDENBRIDGE PHARMS
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215005 · SOMERSET THERAPS LLC
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215969 · SOMERSET THERAPS LLC
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215618 · SOMERSET THERAPS LLC
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 217791 · SOMERSET
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.
