Orange Book product · Brand (NDA)
VOLTAREN
DICLOFENAC SODIUM
At a glance
Jul 28, 1988
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 28, 1988
38 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOFENAC SODIUM
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 019201
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.
- 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.
