FDA.reportPublic FDA data

Application 021234

Type
NDA
Sponsor
INST BIOCHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLECTORDICLOFENAC EPOLAMINESYSTEM;TOPICAL1.3%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021234-001FLECTORDICLOFENAC EPOLAMINE1.3%SYSTEM / TOPICALRLD, RS2007-01-31

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021234-001FLECTOR1.3%SYSTEM / TOPICALRLD, RS2007-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021234-001FLECTOR1.3%SYSTEM / TOPICALRLD, RS2007-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021234-001FLECTOR1.3%SYSTEM / TOPICALRLD, RS2007-01-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021234-001FLECTOR1.3%SYSTEM / TOPICALRLD, RS2007-01-31a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021234-00156076902019-04-13Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021234-00156076902019-04-13Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021234-00156076902019-04-13Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021234-00156076902019-04-13Drug productea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac EpolamineDICLOFENAC EPOLAMINESportpharm LLCa4146abc-814d-4d55-b51d-a3cb576033252026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
Diclofenac EpolamineDICLOFENAC EPOLAMINEHAWAII REPACK, INC.861907f7-a338-41c4-899e-48bd9a7e47492026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
Diclofenac EpolamineDICLOFENAC EPOLAMINEPreferred Pharmaceuticals Inc.1a5c4d2d-a819-4749-b4d4-7f2c099175a42026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
Diclox Patch 30CTDICLOFENAC EPOLAMINE 1.3% PATCHInjecta Medcial LLC526cfe9e-0e22-60c5-e063-6294a90a697f2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
diclofenac epolamineDICLOFENAC EPOLAMINETeva Pharmaceuticals USA Inc.d7bfe17d-e88e-4792-bfba-cea56ed96c3b2026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
ndc (product): 0093-3727
FLECTORDICLOFENAC EPOLAMINEIBSA Pharma Inc.1f19a016-c4fc-43c5-9990-e5f2e2776a822025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
ndc (product): 71858-0405
Diclofenac EpolamineDICLOFENAC EPOLAMINEYARAL Pharma Inc.2d9bfacc-1b0c-4fab-b949-cd0c914089f92025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
ndc (product): 82347-0405
Diclofenac EpolamineDICLOFENAC EPOLAMINEPhoenix RX LLC3fa49554-d85f-a1d5-e063-6294a90a8baf2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
diclofenac epolamineDICLOFENAC EPOLAMINEASCLEMED USA INC.f4471245-83d0-49f5-9cd5-3f7e76c799c42025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
diclofenac epolamineDICLOFENAC EPOLAMINEAdvanced Rx of Tennessee, LLC08b8737f-b6d2-77da-e063-6294a90a1a3e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
diclofenac epolamineDICLOFENAC EPOLAMINEQuality Care Products, LLC73182d59-97ad-44d4-ad9e-680dc575ab862024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
Diclofenac EpolamineDICLOFENAC EPOLAMINEAdvanced Rx Pharmacy of Tennessee, LLC1b563e42-3b06-5320-e063-6294a90a30e52024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234
Diclofenac EpolamineDICLOFENAC EPOLAMINEAsclemed USA, Inc.45e191b6-c6c9-45f9-96d5-cf30f8aa910c2024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021234
application number: NDA021234

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3225diclofenac epolamineDiclofenac EpolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3225diclofenac epolamineDiclofenac EpolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3225diclofenac epolamineDiclofenac EpolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
0093-3727diclofenac epolaminediclofenac epolamineTeva Pharmaceuticals USA Inc.NDA AUTHORIZED GENERICCurrent
21695-707FlectorDiclofenac epolamineRebel Distributors CorpNDACurrent
35356-077FlectorDiclofenac EpolamineQuality Care Products, LLCNDACurrent
35356-077FLECTORDICLOFENAC EPOLAMINELake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
35356-077FlectorDiclofenac EpolamineQuality Care Products, LLCNDACurrent
42254-248FlectorDiclofenac EpolamineRebel Distributors CorpNDACurrent
50090-1195FlectorDiclofenac EpolamineA-S Medication SolutionsNDACurrent
50436-1332FlectorDiclofenac EpolamineUnit Dose ServicesNDACurrent
50436-1335diclofenac epolamineDiclofenac EpolamineUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
50436-3727diclofenac epolaminediclofenac epolamineUnit Dose ServicesNDA AUTHORIZED GENERICCurrent
52959-518FlectorDiclofenac EpolamineH.J. Harkins Company, Inc.NDACurrent
55700-801Diclofenac EpolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-801Diclofenac EpolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-807diclofenac epolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-807diclofenac epolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-886diclofenac epolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-886diclofenac epolamineDiclofenac EpolamineQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
59762-0411Diclofenac EpolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0411Diclofenac EpolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0411Diclofenac EpolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0707diclofenac epolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0707diclofenac epolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0707diclofenac epolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0707diclofenac epolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0707diclofenac epolamineDiclofenac EpolamineGreenstone LLCNDA AUTHORIZED GENERICCurrent
60793-132FLECTORDiclofenac EpolaminePfizer, Inc.NDACurrent
60793-132FLECTORDiclofenac EpolaminePfizer, Inc.NDACurrent
60793-411FlectorDiclofenac EpolaminePfizer, Inc.NDACurrent
60793-411FlectorDiclofenac EpolaminePfizer, Inc.NDACurrent
60793-411FlectorDiclofenac EpolaminePfizer, Inc.NDACurrent
61919-566FLECTORFLECTORDIRECT RXNDACurrent
63629-4762FlectorDiclofenac EpolamineBryant Ranch PrepackNDACurrent
63629-4762FlectorDiclofenac EpolamineBryant Ranch PrepackNDACurrent
68788-6396FlectorDiclofenac EpolaminePreferred Pharmaceucitalc Inc.NDACurrent
68788-6396FlectorDiclofenac EpolaminePreferred Pharmaceucitalc Inc.NDACurrent
70518-3000diclofenac epolamineDiclofenac EpolamineREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3000diclofenac epolamineDiclofenac EpolamineREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-3000diclofenac epolamineDiclofenac EpolamineREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71858-0405FLECTORdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0405FLECTORdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0405FLECTORdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0405FLECTORdiclofenac epolamineIBSA Pharma Inc.NDACurrent
71858-0405FLECTORdiclofenac epolamineIBSA Pharma Inc.NDACurrent
82347-0405Diclofenac EpolamineDiclofenac EpolamineYARAL Pharma Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80385SUPPL 2024-11-25
80384SUPPL 2024-11-25
80303SUPPL 2024-11-22
67355SUPPL2021-05-03
67354SUPPL2021-05-03
67267SUPPL2021-04-30
57902SUPPL2019-03-07
57901SUPPL2019-03-07
57883SUPPL2019-03-04
57882SUPPL2019-03-04
57881SUPPL2019-03-04
57880SUPPL2019-03-04
56349SUPPL2018-11-08
55472SUPPL2018-09-13
55382SUPPL2018-09-05
36428SUPPL2016-05-11
36427SUPPL2016-05-11
27160SUPPL2016-05-11
4724SUPPL2016-05-11
36426SUPPL2011-03-04
27159SUPPL2011-02-28
4723SUPPL2011-02-04
4722SUPPL2011-02-04
14696SUPPL2011-01-31
27158SUPPL2009-11-10
36425SUPPL2009-10-06
14697SUPPL2009-10-06
27157SUPPL2008-10-28
14695SUPPL2008-06-19
4721SUPPL2008-06-06
42044ORIG2008-01-23
27156ORIG2007-02-12
14694ORIG2007-02-02
62969SUPPL1900-01-01