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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020607-001ARTHROTECDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24
N020607-002ARTHROTECDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N020607-001AB
N020607-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020607-001ARTHROTEC50MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD1997-12-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N020607-002ARTHROTEC75MG;0.2MGTABLET, DELAYED RELEASE / ORALABRLD, RS1997-12-24782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020607-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020607-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020607-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020607-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020607-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020607-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020607-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020607-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020607-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020607-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020607-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020607-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020607-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020607-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020607-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020607-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020607-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020607-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020607-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020607-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020607-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020607-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020607-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020607-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020607-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020607-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020607-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020607-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020607-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020607-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020607-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020607-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020607-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020607-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020607-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020607-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020607-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020607-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020607-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N020607-002AB1782e0a99824c…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLMylan Pharmaceuticals Inc.a7701e8c-4e16-4165-8b83-de2c08d5ded32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020607
application number: NDA020607
ndc (product): 59762-0028
ndc (product): 59762-0029
ARTHROTECDICLOFENAC SODIUM AND MISOPROSTOLPfizer Laboratories Div Pfizer Inc600fe842-45d9-4d68-9ef2-456dbbebaa112025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020607
application number: NDA020607
ndc (product): 0025-1411
ndc (product): 0025-1421
Diclofenac sodium and Misoprostol DRDICLOFENAC SODIUM AND MISOPROSTOLAdvanced Rx Pharmacy of Tennessee, LLC1213d3eb-9870-f144-e063-6394a90a60882024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020607
application number: NDA020607

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

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 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
0025-1411ARTHROTECdiclofenac 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
0025-1421ARTHROTECdiclofenac 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