Orange Book product · Brand (NDA)
ATROPINE (AUTOINJECTOR)
ATROPINE
Brand (NDA)NDA 212319DISCN RAFA LABS LTD
At a glance
Jul 09, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2018
8 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ATROPINE
Strength
EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 212319
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.
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.
