Orange Book product · Brand (NDA)
ATROPINE SULFATE
ATROPINE SULFATE
At a glance
Sep 19, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 1990
36 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE SULFATE
Strength
EQ 0.36MG BASE/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 020056
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 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
- 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.
