Orange Book product · Generic (ANDA)
OXYTOCIN
OXYTOCIN
At a glance
Jan 24, 2008
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2008
18 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
10USP UNITS/ML (10USP UNITS/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 077453
Product number
001
Marketing status
DISCN
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
- 2013OXYTOCINGeneric (ANDA)
ANDA 200219 · HIKMA FARMACEUTICA
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.
