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 7 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	PHOENIX RX LLC	41da2e11-58c7-9622-e063-6394a90a9fdb	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	PHOENIX RX LLC	41dab520-5651-a4c5-e063-6394a90a2962	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM	BluePoint Laboratories	feb1541a-de83-47dd-be03-c43376527318	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	Encube Ethicals, Inc.	6e8c45e1-8cd4-4ff7-a758-f9d2ed37e593	2025-10-01	Warnings	Name fallback brand name: DICLOFENAC SODIUM
ARTHRITIS PAIN RELIEVING	DICLOFENAC SODIUM	Walgreen Company	b1850a16-54f1-4210-abdf-26414da8b3d9	2025-09-29	Warnings	Name fallback generic name: DICLOFENAC SODIUM
FOSTER AND THRIVE ARTHRITIS PAIN	DICLOFENAC SODIUM	Strategic Sourcing Services LLC	f9f4e55f-ffad-4df7-9b3c-1e7c3a3723c1	2025-09-27	Warnings	Name fallback generic name: DICLOFENAC SODIUM
DG HEALTH ARTHRITIS PAIN	DICLOFENAC SODIUM	Dolgencorp Inc	6479e4bb-0790-483e-bfe3-a54d549aa5d2	2025-09-15	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	3e15c3db-5245-76fb-e063-6394a90a814e	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	4c5b722e-0d1a-48e9-87c8-9b370b8ced46	2025-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Bryant Ranch Prepack	4e97c685-628a-4b83-ba9e-2d3caf65542b	2025-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	3d71f76d-bb23-7251-e063-6394a90aa9d8	2025-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Best Choice (Valu Merchandisers Company)	4ea809a9-387a-4193-a176-d8b22eaa55e6	2025-08-21	Warnings	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	ca0f9295-4933-48d6-9387-90345fd5dcaa	2025-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
DICLOFENAC SODIUM	DICLOFENAC SODIUM TOPICAL GEL, 1%	BluePoint Laboratories	274543d2-a9a6-1e37-e063-6394a90ae3f1	2025-08-11	Warnings	Name fallback brand name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Rising Pharma Holdings, Inc.	3330ea92-fc9d-4541-b378-be399b0995d3	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	PHOENIX RX LLC	3a4f7301-aa1c-9064-e063-6294a90a6eb4	2025-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	PHOENIX RX LLC	3a63e26f-27d7-9a25-e063-6294a90a55fe	2025-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
DICLOFENAC SODIUM	DICLOFENAC	Encube Ethicals, Inc.	e7304b3e-530a-4519-aed0-bed4512d8925	2025-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: DICLOFENAC SODIUM
MEMBERS MARK ARTHRITIS PAIN RELIEVER	DICLOFENAC SODIUM	Sam's West Inc	d339aaa2-ae7e-4a79-b687-cf0a3106fad0	2025-07-16	Warnings	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	39e67a90-df3e-ad30-e063-6394a90a7a82	2025-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback 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