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 10 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	NuCare Pharmaceuticals,Inc.	62edf474-9c16-d535-e053-2991aa0a4a09	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	81bfeada-6589-4528-bea5-059ab0fabb43	2025-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NorthStar Rx LLC	fd467c1a-6463-4d92-9960-3e308c733edb	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium Delayed Release	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	5b4c1a15-ed93-7192-e053-2991aa0a8360	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	ad193f94-f8d0-8482-e053-2995a90a35a4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	b3dbd981-453c-645f-e053-2a95a90aec3c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0803345d-7811-bc21-e063-6394a90aa661	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	d424ab84-2aaa-38a9-e053-2a95a90adde9	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	ec06cca5-3436-10c8-e053-2995a90a4aeb	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium ER	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	ecaa39b8-067c-80d7-e053-2a95a90a7354	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7267-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1896c84-b18a-d49d-e053-2995a90aaab3	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7264-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f3d27ae6-1259-5375-e053-2995a90a572d	2024-12-31	Warnings	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f187ae44-71be-a682-e053-2995a90a6426	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium	DICLOFENAC	Advanced Rx Pharmacy of Tennessee, LLC	fc100cb2-16d9-f67d-e053-6294a90a0f2e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Advanced Rx Pharmacy of Tennessee, LLC	fc0e6a51-bec3-f7ee-e053-6394a90ada9a	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Diclofenac Sodium
Diclofenac sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	fc0e1950-d76f-75bc-e053-6294a90a8c12	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Diclofenac sodium generic name: DICLOFENAC SODIUM
Diclofenac Sodium DR	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	af8a1392-67e8-8201-e053-2a95a90a0fce	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: DICLOFENAC SODIUM
Diclofenac sodium	DICLOFENAC SODIUM	Quality Care Products, LLC	3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b	2024-12-19	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