Orange Book product · Generic (ANDA)
DICLOFENAC SODIUM AND MISOPROSTOL
DICLOFENAC SODIUM; MISOPROSTOL
At a glance
Jul 09, 2012
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2012
14 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Strength
50MG;0.2MG
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 201089
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DICLOFENAC SODIUM; MISOPROSTOL
- 1997ARTHROTECBrand (NDA)
NDA 020607 · PFIZER
- 2023DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 206771 · ZYDUS PHARMS
- 2021DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 204355 · MICRO LABS
- 2020DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 205143 · YUNG SHIN PHARM
- 2016DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 203995 · AMNEAL PHARMS
- 2014DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 200540 · EXELA HOLDINGS
- 2013DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 200158 · SANDOZ
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.
