Application 076152

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076152-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2001-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076152-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2001-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2001-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2001-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2001-12-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076152-001	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE / ORAL	2001-12-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-11-14 07:37:17	2026-10	A076152-001	AB	1	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A076152-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A076152-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076152-001	AB	1	`caaa826d4ba7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Aurobindo Pharma Limited	d9b6f1d0-1710-46fb-8ea4-80b3ca60a575	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076152 application number: ANDA076152

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0355	Diclofenac Sodium	Diclofenac Sodium	Mylan Pharmaceuticals Inc	ANDA	Current
43063-270	Diclofenac Sodium	Diclofenac Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55700-604	Diclofenac Sodium	Diclofenac Sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-604	Diclofenac Sodium	Diclofenac Sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current