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

NDC Listings For This Application#

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