Orange Book product · Brand (NDA)
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%
OXYTOCIN
At a glance
Mar 29, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 1985
41 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
OXYTOCIN
Strength
1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019185
Product number
001
Marketing status
DISCN
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.
- —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
- 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.
