Orange Book product · Brand (NDA)
PITOCIN
OXYTOCIN
At a glance
Jul 27, 2007
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2007
19 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
100USP UNITS/10ML (10USP UNITS/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 018261
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 018248 · FRESENIUS KABI USA
- —OXYTOCINBrand (NDA)
NDA 018243 · HIKMA
- —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.
