Application 204132

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	SOLUTION;TOPICAL	1.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204132-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2015-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204132-001	AT

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204132-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204132-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204132-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204132-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204132-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204132-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204132-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204132-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204132-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204132-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204132-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204132-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204132-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204132-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204132-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204132-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204132-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204132-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204132-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204132-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204132-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204132-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204132-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204132-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204132-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204132-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204132-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204132-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204132-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204132-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204132-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204132-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204132-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204132-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204132-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204132-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204132-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204132-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204132-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204132-001	AT	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	SOLA Pharmaceuticals	c3f33952-44a8-71b2-e053-2a95a90abda2	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 70512-038
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	PHOENIX RX LLC	3b40a448-3f5e-fe6f-e063-6394a90a32df	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	a5b33bf7-8113-9c54-e053-2995a90a79d8	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 72189-273
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	Preferred Pharmaceuticals Inc.	dbcd42cf-d44a-4d47-9149-66ffcf9a0587	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 68788-8084
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	f18a4691-93a1-01e6-e053-2995a90a0069	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	Proficient Rx LP	90b25b9b-3930-48af-b139-d24f2fccfcdc	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 71205-640
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8	2021-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 76420-134
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	20107264-e533-4de9-9a37-59fde7981c92	2020-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 63187-791

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-878	Diclofenac Sodium	Diclofenac Sodium	medsource pharmaceuticals	ANDA	Current
50090-4019	Diclofenac Sodium	Diclofenac Sodium	A-S Medication Solutions	ANDA	Current
50436-3338	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Unit Dose Services	ANDA	Current
51021-250	Diclofenac Sodium	Diclofenac Sodium	Sircle Laboratories, LLC	ANDA	Current
51021-372	Diclofex DC	Diclofenac Sodium and Capsaicin	Sircle Laboratories, LLC	ANDA	Current
51021-379	Diclofex DC	Diclofenac Sodium and Capsaicin Oleoresin	Sircle Laboratories, LLC	ANDA	Current
51021-379	Diclofex DC	Diclofenac Sodium and Capsaicin Oleoresin	Sircle Laboratories, LLC	ANDA	Current
51021-582	Dynabac 5.0	Diclofenac Sodium and CANNABIDIOL	Sircle Laboratories, LLC	ANDA	Current
51021-582	Dynabac 5.0	Diclofenac Sodium and CANNABIDIOL	Sircle Laboratories, LLC	ANDA	Current
55700-931	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Quality Care Products, LLC	ANDA	Current
55700-931	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Quality Care Products, LLC	ANDA	Current
61919-874	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
61919-874	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
63187-791	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63187-791	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
63187-791	Diclofenac Sodium	Diclofenac Sodium	Proficient Rx LP	ANDA	Current
68180-538	Diclofenac Sodium	Diclofenac Sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-538	Diclofenac Sodium	Diclofenac Sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-538	Diclofenac Sodium	Diclofenac Sodium	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-8084	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8084	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Preferred Pharmaceuticals Inc.	ANDA	Current
69336-203	Diclopak	diclofenac sodium, capsaicin	Sterling-Knight Pharmaceuticals, LLC	ANDA	Current
70512-038	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	SOLA Pharmaceuticals	ANDA	Current
70512-038	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	SOLA Pharmaceuticals	ANDA	Current
70512-038	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	SOLA Pharmaceuticals	ANDA	Current
70981-601	Kapzin DC	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, Inc	ANDA	Current
70981-701	Diclosiacin	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, LLC	ANDA	Current
70981-701	Diclosiacin	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, LLC	ANDA	Current
70981-701	Diclosiacin	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, LLC	ANDA	Current
70981-702	Diclosaicin	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, Inc	ANDA	Current
70981-750	Iclofenac CP	Diclofenac Sodium and Capsaicin	Chadwick Pharmaceuticals, Inc	ANDA	Current
71205-640	Diclofenac Sodium 1.5%	Diclofenac Sodium Topical	Proficient Rx LP	ANDA	Current
72189-273	DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	ANDA	Current
73247-201	Capsinac	Diclofenac Sodium and Capsaicin	Bodysphere, LLC	ANDA	Current
73247-201	Capsinac	Diclofenac Sodium and Capsaicin	Bodysphere, LLC	ANDA	Current
73516-450	Profinac	Diclofenac Sodium	Ashoka Health	ANDA	Current
73516-605	Biifenac 500	Diclofenac Sodium and MENTHOL, UNSPECIFIED FORM	Ashoka Health	ANDA	Current
73516-605	Biifenac 500	Diclofenac Sodium and MENTHOL, UNSPECIFIED FORM	Ashoka Health	ANDA	Current
73516-605	Biifenac 500	Diclofenac Sodium and MENTHOL, UNSPECIFIED FORM	Ashoka Health	ANDA	Current
73516-610	Biifenac 1000	Diclofenac Sodium and MENTHOL, UNSPECIFIED FORM	Ashoka Health	ANDA	Current
73516-610	Biifenac 1000	Diclofenac Sodium and MENTHOL, UNSPECIFIED FORM	Ashoka Health	ANDA	Current
73516-801	Ziclopro	Diclofenac Sodium and Capsaicin	Ashoka Health	ANDA	Current
76420-134	Diclofenac Sodium	Diclofenac Sodium	Asclemed USA, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32514	ORIG	2015-08-25