Orange Book product · Brand (NDA)
ATROPINE SULFATE
ATROPINE SULFATE
At a glance
Mar 15, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE
Strength
1%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 213581
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.
- 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
- 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.
