FDA.reportPublic FDA data

Application 200540

Type
ANDA
Sponsor
EXELA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL50MG;0.2MGNoNo
002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOLTABLET, DELAYED RELEASE;ORAL75MG;0.2MGNoNo

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

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
A200540-001DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14
A200540-002DICLOFENAC SODIUM AND MISOPROSTOLDICLOFENAC SODIUM; MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A200540-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A200540-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200540-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14e64feba35796…
2022-09-29 23:25 UTC2022-09A200540-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200540-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200540-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A200540-001DICLOFENAC SODIUM AND MISOPROSTOL50MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A200540-002DICLOFENAC SODIUM AND MISOPROSTOL75MG;0.2MGTABLET, DELAYED RELEASE / ORAL2014-03-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A200540-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A200540-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200540-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A200540-002AB1ea99ee380514…

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 · 6 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-de2c08d5ded32026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac sodium and Misoprostol
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLActavis Pharma, Inc.df8b8660-0c24-4848-8bea-c1b935090c662026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium and Misoprostol
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAvKARE3643ab1b-9f8f-b2f4-e02d-950d0a02e5872026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium and Misoprostol
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBluePoint Laboratories9a22cb4b-e49a-4bd7-b235-47405c3026582025-09-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium and Misoprostol
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLAmneal Pharmaceuticals LLCafd30051-8f59-474b-9972-962a5a871dfb2025-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium and Misoprostol
Diclofenac Sodium and MisoprostolDICLOFENAC SODIUM AND MISOPROSTOLBryant Ranch Prepackd6671b66-00ad-4949-b51a-36e1130b1cb52025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diclofenac Sodium and Misoprostol

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-955Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolBlenheim Pharmacal, Inc.ANDACurrent
42367-110Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolEagle Pharmaceuticals, Inc.ANDACurrent
42367-111Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolEagle Pharmaceuticals, Inc.ANDACurrent
69339-123Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolDash Pharmaceuticals LLCANDACurrent
69339-124Diclofenac Sodium and MisoprostolDiclofenac Sodium and MisoprostolDash Pharmaceuticals LLCANDACurrent