Application 074432

Type: ANDA
Sponsor: PLIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	50MG	No	No
003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	TABLET, DELAYED RELEASE;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074432-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL			1999-07-29
A074432-003	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL			1999-07-29

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 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074432-002	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074432-003	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	1999-07-29	`74a2ff9319b5…`

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 6 of 16 · 312 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
UP AND UP ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Target Corporation	3a9b32af-a3cd-496b-9698-0421443e0385	2025-12-08	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM 1%	SOLA Pharmaceuticals	bdbe3f24-3015-1f32-e053-2995a90aa665	2025-12-08	Warnings	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	4539e9e7-5d82-3b36-e063-6394a90a1396	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Aleve Arthritis Pain Gel	DICLOFENAC SODIUM	Bayer HealthCare LLC	bad675d1-1204-0136-e053-2995a90a994e	2025-12-04	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Proficient Rx LP	140a2c64-4996-4da3-b10f-1b8235ebde9d	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Alembic Pharmaceuticals Inc.	30c3c3c5-b4f3-4321-ae25-b2c588ad0551	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	b8072af2-9940-4827-9fbd-de46ad8bf929	2025-11-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	H E B	027803c5-85ae-4b86-8bd4-e61f8f34d036	2025-11-17	Warnings	Name fallback generic name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Meijer, Inc.	5cc570c6-2585-4d1a-9352-b1161458af9a	2025-11-17	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	PHOENIX RX LLC	41472cca-278b-934b-e063-6294a90aaf5d	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	4382cc15-8978-4f3b-e063-6394a90a9ecb	2025-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Topical 1%	DICLOFENAC SODIUM	YYBA CORP	043df5d2-6f3e-311f-e063-6294a90a23d7	2025-11-10	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0b4fd47f-903c-097b-e063-6394a90a49ab	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Lupin Pharmaceuticals, Inc.	609c5344-9c97-4fa8-ad53-d0f622ce64ec	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Dr. Reddy's Laboratories Inc.	c88b2512-0255-658d-252a-c006275159b0	2025-10-28	Warnings	Name fallback brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Chain Drug Marketing Association INC	625d21e8-0731-1157-30fe-9f9868ff8dc4	2025-10-28	Warnings	Name fallback brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	GERI-CARE PHARMACEUTICALS CORP	91fc618a-edd0-5944-083f-c00075476f55	2025-10-28	Warnings	Name fallback brand name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM	GLENMARK PHARMACEUTICALS INC., USA	dab3ae60-0135-43b3-a1d0-8752720af82a	2025-10-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM generic name: DICLOFENAC SODIUM

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8413	ORIG	1999-07-29