Orange Book product · Generic (ANDA)
ATROPINE SULFATE
ATROPINE SULFATE
At a glance
Mar 19, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 2021
5 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE
Strength
8MG/20ML (0.4MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL
TE code
AP
Application
ANDA 213424
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
- 2025ATROPINE SULFATEGeneric (ANDA)
ANDA 217345 · HIKMA
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215005 · SOMERSET THERAPS LLC
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215969 · SOMERSET THERAPS LLC
- 2024ATROPINE SULFATEGeneric (ANDA)
ANDA 215618 · SOMERSET THERAPS LLC
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.
