FDA.reportPublic FDA data

Application 020607

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARTHROTECDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL50MG;0.2MGYesNo
002ARTHROTECDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL75MG;0.2MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1411ARTHROTECdiclofenac sodium and misoprostolG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
0025-1421ARTHROTECdiclofenac sodium and misoprostolPfizer Laboratories Div Pfizer IncNDACurrent
21695-425ARTHROTECdiclofenac sodium and misoprostolRebel Distributors Corp.NDACurrent
49999-987ARTHROTECdiclofenac sodium and misoprostolLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
55289-406ARTHROTECdiclofenac sodium and misoprostolPD-Rx Pharmaceuticals, Inc.NDACurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0028Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0029Diclofenac sodium and MisoprostolDiclofenac sodium and MisoprostolGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80410SUPPL 2024-11-25
80409SUPPL 2024-11-25
80280SUPPL 2024-11-22
73041SUPPL2022-12-27
73021SUPPL2022-12-23
71969SUPPL2022-08-30
71968SUPPL2022-08-30
71938SUPPL2022-08-29
68292SUPPL2021-08-05
68274SUPPL2021-08-03
67400SUPPL2021-05-04
67255SUPPL2021-04-29
64685SUPPL2020-09-25
64683SUPPL2020-09-25
64677SUPPL2020-09-25
64144SUPPL2020-07-30
64143SUPPL2020-07-30
64120SUPPL2020-07-29
25316SUPPL2016-05-12
12841SUPPL2016-05-11
25315SUPPL2015-04-03
34952SUPPL2015-04-02
12840SUPPL2014-09-09
2868SUPPL2014-09-05
34953SUPPL2013-03-08
2867SUPPL2013-03-08
34951SUPPL2010-12-22
25314SUPPL2010-12-22
2866SUPPL2009-11-10
23167ORIG2009-10-30
12839SUPPL2009-10-06
34950SUPPL2009-03-17
25313SUPPL2009-02-27
25312SUPPL2007-08-27
12838SUPPL2007-08-27
2865SUPPL2006-01-30
12837SUPPL2006-01-25
2864SUPPL2005-07-15
41478ORIG2003-08-08
41479SUPPL1999-02-22