Orange Book product · Generic (ANDA)
DICLOFENAC SODIUM AND MISOPROSTOL
DICLOFENAC SODIUM; MISOPROSTOL
At a glance
Jul 15, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 15, 2021
5 yr 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 204355
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
- 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
- 2012DICLOFENAC SODIUM AND MISOPROSTOLGeneric (ANDA)
ANDA 201089 · ACTAVIS LABS FL INC
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.
