FDA Orange Book · active-ingredient family
Oxytocin
Oxytocin is approved as 6 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OXYTOCIN 10 USP UNITS IN DEXTROSE 5% · NDA 019185
6
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYTOCIN 10 USP UNITS IN DEXTROSE 5%RLD×4 | ABBOTT | NDA 019185 | — | Mar 29, 1985 | |
| OXYTOCINRLD×3 | FRESENIUS KABI USA | NDA 018248 | AP | Approved Prior to Jan 1, 1982 | |
| OXYTOCINRLD×2 | HIKMA | NDA 018243 | AP | Approved Prior to Jan 1, 1982 | |
| PITOCINRLD×3 | PH HEALTH | NDA 018261 | AP | Approved Prior to Jan 1, 1982 | |
| SYNTOCINON | NOVARTIS | NDA 018245 | — | Approved Prior to Jan 1, 1982 | |
| SYNTOCINON | RTRX | NDA 012285 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYTOCIN×2 | SAGENT PHARMS INC | ANDA 091676 | AP | Jul 13, 2018 | |
| OXYTOCIN | HIKMA FARMACEUTICA | ANDA 200219 | AP | Feb 13, 2013 | |
| OXYTOCIN×2 | DR REDDYS | ANDA 077453 | — | Jan 24, 2008 |
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.
Oxytocin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
