Orange Book product · Brand (NDA)
VOLTAREN
DICLOFENAC SODIUM
At a glance
Mar 28, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 1991
35 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOFENAC SODIUM
Strength
0.1%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 020037
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
- 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
- 2022DICLOFENAC SODIUMGeneric (ANDA)
ANDA 208198 · AMNEAL
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.
