Orange Book product · Generic (ANDA)
OXYTOCIN
OXYTOCIN
At a glance
Feb 13, 2013
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2013
13 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
10USP UNITS/ML (10USP UNITS/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 200219
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXYTOCIN
- 1985OXYTOCIN 10 USP UNITS IN DEXTROSE 5%Brand (NDA)
NDA 019185 · ABBOTT
- —OXYTOCINBrand (NDA)
NDA 018248 · FRESENIUS KABI USA
- —OXYTOCINBrand (NDA)
NDA 018243 · HIKMA
- —PITOCINBrand (NDA)
NDA 018261 · PH HEALTH
- —SYNTOCINONBrand (NDA)
NDA 018245 · NOVARTIS
- —SYNTOCINONBrand (NDA)
NDA 012285 · RTRX
- 2018OXYTOCINGeneric (ANDA)
ANDA 091676 · SAGENT PHARMS INC
- 2008OXYTOCINGeneric (ANDA)
ANDA 077453 · DR REDDYS
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.
