Orange Book product · Brand (NDA)
OXYTOCIN
OXYTOCIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
100USP UNITS/10ML (10USP UNITS/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018248
Product number
002
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.
- 1985OXYTOCIN 10 USP UNITS IN DEXTROSE 5%Brand (NDA)
NDA 019185 · ABBOTT
- —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
- 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.
