FDA.reportPublic FDA data

Application 213127

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213127-001CELECOXIBCELECOXIB100MGCAPSULE / ORAL2025-04-29
A213127-002CELECOXIBCELECOXIB200MGCAPSULE / ORAL2025-04-29
A213127-003CELECOXIBCELECOXIB400MGCAPSULE / ORAL2025-04-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-29a50c72e98297…

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 7 · 134 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy57b07096-6d7c-1653-e063-6294a90aa6e22026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBAmerican Health Packaging4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc72026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy3bc74e76-0517-69c6-e063-6394a90abe752026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBHAWAII REPACK, INC.45816eae-ad83-4d2f-a035-c3f9f24708f92026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepackd94849a7-1831-4319-982c-c6b20dc420382026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.f5d0e5b9-97d8-42a4-a0a0-c09dde7008e62026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBBryant Ranch Prepackfd569104-8243-48fa-8e93-5a08654ad6dd2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBRedpharm Drug5250529a-6a03-78a1-e063-6294a90a47f92026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.52572bfb-43f0-4b55-b1fd-231a05c8b83e2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAvPAK951df0f7-5fb7-40f5-e053-2995a90a1edd2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.56d64558-1fad-420e-8fcd-7103cd0731272026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB