Orange Book product · Brand (NDA)
ATROPINE SULFATE
ATROPINE SULFATE
At a glance
Jan 26, 2018
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2018
8 yr 6 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
NDA 209260
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022ATROPINE SULFATEBrand (NDA)
NDA 213581 · BAUSCH AND LOMB INC
- 2020ATROPINE SULFATEBrand (NDA)
NDA 214652 · ACCORD HLTHCARE
- 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
- 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.
