Application 021234

Type: NDA
Sponsor: INST BIOCHEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLECTOR	DICLOFENAC EPOLAMINE	SYSTEM;TOPICAL	1.3%	Yes	Yes

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
N021234-001	FLECTOR	DICLOFENAC EPOLAMINE	1.3%	SYSTEM / TOPICAL		RLD, RS	2007-01-31

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021234-001	5607690	2019-04-13	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021234-001	5607690	2019-04-13	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021234-001	5607690	2019-04-13	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021234-001	5607690	2019-04-13	Drug product	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	HAWAII REPACK, INC.	861907f7-a338-41c4-899e-48bd9a7e4749	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Preferred Pharmaceuticals Inc.	1a5c4d2d-a819-4749-b4d4-7f2c099175a4	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclox Patch 30CT	DICLOFENAC EPOLAMINE 1.3% PATCH	Injecta Medcial LLC	526cfe9e-0e22-60c5-e063-6294a90a697f	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Teva Pharmaceuticals USA Inc.	d7bfe17d-e88e-4792-bfba-cea56ed96c3b	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234 ndc (product): 0093-3727
FLECTOR	DICLOFENAC EPOLAMINE	IBSA Pharma Inc.	1f19a016-c4fc-43c5-9990-e5f2e2776a82	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234 ndc (product): 71858-0405
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	YARAL Pharma Inc.	2d9bfacc-1b0c-4fab-b949-cd0c914089f9	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234 ndc (product): 82347-0405
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Phoenix RX LLC	3fa49554-d85f-a1d5-e063-6294a90a8baf	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	ASCLEMED USA INC.	f4471245-83d0-49f5-9cd5-3f7e76c799c4	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Advanced Rx of Tennessee, LLC	08b8737f-b6d2-77da-e063-6294a90a1a3e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Quality Care Products, LLC	73182d59-97ad-44d4-ad9e-680dc575ab86	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Advanced Rx Pharmacy of Tennessee, LLC	1b563e42-3b06-5320-e063-6294a90a30e5	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Asclemed USA, Inc.	45e191b6-c6c9-45f9-96d5-cf30f8aa910c	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-3225	diclofenac epolamine	Diclofenac Epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3225	diclofenac epolamine	Diclofenac Epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3225	diclofenac epolamine	Diclofenac Epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
0093-3727	diclofenac epolamine	diclofenac epolamine	Teva Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
21695-707	Flector	Diclofenac epolamine	Rebel Distributors Corp	NDA	Current
35356-077	Flector	Diclofenac Epolamine	Quality Care Products, LLC	NDA	Current
35356-077	FLECTOR	DICLOFENAC EPOLAMINE	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	NDA	Current
35356-077	Flector	Diclofenac Epolamine	Quality Care Products, LLC	NDA	Current
42254-248	Flector	Diclofenac Epolamine	Rebel Distributors Corp	NDA	Current
50090-1195	Flector	Diclofenac Epolamine	A-S Medication Solutions	NDA	Current
50436-1332	Flector	Diclofenac Epolamine	Unit Dose Services	NDA	Current
50436-1335	diclofenac epolamine	Diclofenac Epolamine	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
50436-3727	diclofenac epolamine	diclofenac epolamine	Unit Dose Services	NDA AUTHORIZED GENERIC	Current
52959-518	Flector	Diclofenac Epolamine	H.J. Harkins Company, Inc.	NDA	Current
55700-801	Diclofenac Epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-801	Diclofenac Epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-807	diclofenac epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-807	diclofenac epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-886	diclofenac epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
55700-886	diclofenac epolamine	Diclofenac Epolamine	Quality Care Products, LLC	NDA AUTHORIZED GENERIC	Current
59762-0411	Diclofenac Epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0411	Diclofenac Epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0411	Diclofenac Epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0707	diclofenac epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0707	diclofenac epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0707	diclofenac epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0707	diclofenac epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0707	diclofenac epolamine	Diclofenac Epolamine	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
60793-132	FLECTOR	Diclofenac Epolamine	Pfizer, Inc.	NDA	Current
60793-132	FLECTOR	Diclofenac Epolamine	Pfizer, Inc.	NDA	Current
60793-411	Flector	Diclofenac Epolamine	Pfizer, Inc.	NDA	Current
60793-411	Flector	Diclofenac Epolamine	Pfizer, Inc.	NDA	Current
60793-411	Flector	Diclofenac Epolamine	Pfizer, Inc.	NDA	Current
61919-566	FLECTOR	FLECTOR	DIRECT RX	NDA	Current
63629-4762	Flector	Diclofenac Epolamine	Bryant Ranch Prepack	NDA	Current
63629-4762	Flector	Diclofenac Epolamine	Bryant Ranch Prepack	NDA	Current
68788-6396	Flector	Diclofenac Epolamine	Preferred Pharmaceucitalc Inc.	NDA	Current
68788-6396	Flector	Diclofenac Epolamine	Preferred Pharmaceucitalc Inc.	NDA	Current
70518-3000	diclofenac epolamine	Diclofenac Epolamine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3000	diclofenac epolamine	Diclofenac Epolamine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-3000	diclofenac epolamine	Diclofenac Epolamine	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
71858-0405	FLECTOR	diclofenac epolamine	IBSA Pharma Inc.	NDA	Current
71858-0405	FLECTOR	diclofenac epolamine	IBSA Pharma Inc.	NDA	Current
71858-0405	FLECTOR	diclofenac epolamine	IBSA Pharma Inc.	NDA	Current
71858-0405	FLECTOR	diclofenac epolamine	IBSA Pharma Inc.	NDA	Current
71858-0405	FLECTOR	diclofenac epolamine	IBSA Pharma Inc.	NDA	Current
82347-0405	Diclofenac Epolamine	Diclofenac Epolamine	YARAL Pharma Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80385	SUPPL	2024-11-25
80384	SUPPL	2024-11-25
80303	SUPPL	2024-11-22
67355	SUPPL	2021-05-03
67354	SUPPL	2021-05-03
67267	SUPPL	2021-04-30
57902	SUPPL	2019-03-07
57901	SUPPL	2019-03-07
57883	SUPPL	2019-03-04
57882	SUPPL	2019-03-04
57881	SUPPL	2019-03-04
57880	SUPPL	2019-03-04
56349	SUPPL	2018-11-08
55472	SUPPL	2018-09-13
55382	SUPPL	2018-09-05
36428	SUPPL	2016-05-11
36427	SUPPL	2016-05-11
27160	SUPPL	2016-05-11
4724	SUPPL	2016-05-11
36426	SUPPL	2011-03-04
27159	SUPPL	2011-02-28
4723	SUPPL	2011-02-04
4722	SUPPL	2011-02-04
14696	SUPPL	2011-01-31
27158	SUPPL	2009-11-10
36425	SUPPL	2009-10-06
14697	SUPPL	2009-10-06
27157	SUPPL	2008-10-28
14695	SUPPL	2008-06-19
4721	SUPPL	2008-06-06
42044	ORIG	2008-01-23
27156	ORIG	2007-02-12
14694	ORIG	2007-02-02
62969	SUPPL	1900-01-01