Orange Book product · Brand (NDA)
PITOCIN
OXYTOCIN
At a glance
Sep 05, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 05, 2012
14 yr ago
Today
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
500USP UNITS/50ML (10USP UNITS/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018261
Product number
003
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.
