Application 204519

Type
ANDA
Sponsor
ALEMBIC PHARMS 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 42.

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
A204519-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2015-08-21
A204519-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-08-21
A204519-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-08-21
A204519-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204519-001AB
A204519-002AB
A204519-003AB
A204519-004AB

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-001CELECOXIB50MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-002CELECOXIB100MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-003CELECOXIB200MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-004CELECOXIB400MGCAPSULE / ORALAB2015-08-21d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204519-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204519-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204519-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204519-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204519-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204519-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204519-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204519-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204519-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204519-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204519-004AB1d8e5a09893c0…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAlembic Pharmaceuticals Inc.806e5f8a-f986-4f88-ba3e-8265f86afa482026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 62332-140
ndc (product): 62332-143
ndc (product): 62332-142
ndc (product): 62332-141
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBAvPAK951df0f7-5fb7-40f5-e053-2995a90a1edd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 50268-168
ndc (product): 50268-169
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBRedPharm Drug2fbaa580-f33a-417d-e063-6294a90ad7df2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 46708-270
ndc (product): 46708-267
ndc (product): 46708-269
ndc (product): 46708-268
Celecoxib 200 mgCELECOXIBProficient Rx LPfeee6a01-63f9-42c3-8bd8-ca713a08b36d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 63187-633
CelecoxibCELECOXIBProficient Rx LP7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 71205-020
CelecoxibCELECOXIBProficient Rx LPc787b0ab-77ab-4f7e-9fea-be2a0085020a2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204519
application number: ANDA204519
ndc (product): 71205-055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-658CelecoxibCelecoxibTrigen Laboratories, LLCANDACurrent
13811-659CelecoxibCelecoxibTrigen Laboratories, LLCANDACurrent
13811-660CelecoxibCelecoxibTrigen Laboratories, LLCANDACurrent
13811-661CelecoxibCelecoxibTrigen Laboratories, LLCANDACurrent
45865-943CelecoxibCelecoxibmedsource pharmaceuticalsANDACurrent
46708-267CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-267CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-268CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-268CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-269CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-269CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-270CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
46708-270CelecoxibCelecoxibAlembic Pharmaceuticals LimitedANDACurrent
50268-168CelecoxibCelecoxibAvPAKANDACurrent
50268-168CelecoxibCelecoxibAvPAKANDACurrent
50268-168CelecoxibCelecoxibAvPAKANDACurrent
50268-168CelecoxibCelecoxibAvPAKANDACurrent
50268-169CelecoxibCelecoxibAvPAKANDACurrent
50268-169CelecoxibCelecoxibAvPAKANDACurrent
50268-169CelecoxibCelecoxibAvPAKANDACurrent
50268-169CelecoxibCelecoxibAvPAKANDACurrent
53002-1338CelecoxibCelecoxibRPK Pharmaceuticals, Inc.ANDACurrent
53002-1338CelecoxibCelecoxibRPK Pharmaceuticals, Inc.ANDACurrent
53217-206Celecoxib 200 mgCELECOXIBAidarex Pharmaceuticals LLCANDACurrent
59088-723CeleXib 100-EZSCelecoxibPureTek CorporationANDACurrent
62332-140CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-140CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-140CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-140CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-140CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-141CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-141CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-141CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-141CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-141CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-142CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-142CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-142CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-142CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-142CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-143CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-143CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-143CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-143CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
62332-143CelecoxibCelecoxibAlembic Pharmaceuticals Inc.ANDACurrent
63187-633Celecoxib 200 mgCELECOXIBProficient Rx LPANDACurrent
63187-633Celecoxib 200 mgCELECOXIBProficient Rx LPANDACurrent
67296-1600CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1600CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1600CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
68071-4476CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4476CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8969Celecoxib 200 mgCELECOXIBPreferred Pharmaceuticals Inc.ANDACurrent
69399-182Celecoxib 50 mgCELECOXIBSYDON LABS LLCANDACurrent
69399-183Celecoxib 100 mgCELECOXIBSYDON LABS LLCANDACurrent
69399-184Celecoxib 200 mgCELECOXIBSYDON LABS LLCANDACurrent
69399-185Celecoxib 400 mgCELECOXIBSYDON LABS LLCANDACurrent
69399-194Celecoxib 200 mgCELECOXIBSYDON LABS LLCANDACurrent
71205-020CelecoxibCelecoxibProficient Rx LPANDACurrent
71205-020CelecoxibCelecoxibProficient Rx LPANDACurrent
71205-055CelecoxibCelecoxibProficient Rx LPANDACurrent
71205-055CelecoxibCelecoxibProficient Rx LPANDACurrent
80175-0142celecoxibcelecoxibCentral PackagingANDACurrent
80175-0142celecoxibcelecoxibCentral PackagingANDACurrent