Orange Book product · Generic (ANDA)
DICLOFENAC SODIUM
DICLOFENAC SODIUM
At a glance
May 16, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 16, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOFENAC SODIUM
Strength
1%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
ANDA 211253
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DICLOFENAC SODIUM
- 2014DYLOJECTBrand (NDA)
NDA 022396 · JAVELIN PHARMS INC
- 2014PENNSAIDBrand (NDA)
NDA 204623 · HORIZON
- 2009PENNSAIDBrand (NDA)
NDA 020947 · NUVO PHARMS INC
- 2007VOLTAREN ARTHRITIS PAINBrand (NDA)
NDA 022122 · HALEON US HOLDINGS
- 2000SOLARAZEBrand (NDA)
NDA 021005 · FOUGERA PHARMS
- 1998DICLOFENAC SODIUMBrand (NDA)
NDA 020809 · FALCON PHARMS
- 1991VOLTARENBrand (NDA)
NDA 020037 · NOVARTIS
- 2025DICLOFENAC SODIUMGeneric (ANDA)
ANDA 217646 · ENCUBE
- 2023DICLOFENAC SODIUMGeneric (ANDA)
ANDA 213040 · AUROLIFE PHARMA LLC
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 212506 · ALEMBIC
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208098 · SUN PHARMA CANADA
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208021 · LUPIN PHARMS
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.
