FDA.reportPublic FDA data

Application 211412

Type
ANDA
Sponsor
YILING PHARM LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL50MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
004CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211412-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2020-03-06
A211412-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2020-03-06
A211412-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2020-03-06
A211412-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2020-03-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A211412-001AB
A211412-002AB
A211412-003AB
A211412-004AB

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
2026-08-01 22:54:322026-06A211412-001CELECOXIB50MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-002CELECOXIB100MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-003CELECOXIB200MGCAPSULE / ORALAB2020-03-06a50c72e98297…
2026-08-01 22:54:322026-06A211412-004CELECOXIB400MGCAPSULE / ORALAB2020-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211412-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A211412-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAvet Pharmaceuticals Inc.4bc96d0c-b484-3cee-e063-6294a90a91932026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412
CelecoxibCELECOXIBYiling Pharmaceutical, Inc.43979279-867b-4303-8f30-fc58ae75a0692025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412
ndc (product): 69117-0022
ndc (product): 69117-0023
ndc (product): 69117-0021
ndc (product): 69117-0020
CelecoxibCELECOXIBChartwell RX, LLCa99a67f3-ccaa-4d54-8922-d6dd30fba2742025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211412
application number: ANDA211412
ndc (product): 62135-021
ndc (product): 62135-023
ndc (product): 62135-022

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-021CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-021CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-021CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-022CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-022CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-022CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-023CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-023CelecoxibCelecoxibChartwell RX, LLCANDACurrent
62135-023CelecoxibCelecoxibChartwell RX, LLCANDACurrent
69117-0020CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0020CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0020CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0020CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0021CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0021CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0021CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0021CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0022CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0022CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0022CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0022CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0023CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0023CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0023CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
69117-0023CelecoxibCelecoxibYiling Pharmaceutical, Inc.ANDACurrent
81288-020CelecoxibCelecoxibEMC PHARMA, LLCANDACurrent
81288-021CelecoxibCelecoxibEMC PHARMA, LLCANDACurrent
81288-022CelecoxibCelecoxibEMC PHARMA, LLCANDACurrent
81288-023CelecoxibCelecoxibEMC PHARMA, LLCANDACurrent