Application 204776

Type
ANDA
Sponsor
MICRO LABS

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
A204776-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2018-04-30
A204776-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2018-04-30
A204776-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2018-04-30
A204776-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204776-001AB
A204776-002AB
A204776-003AB
A204776-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204776-001CELECOXIB50MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-002CELECOXIB100MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-003CELECOXIB200MGCAPSULE / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-004CELECOXIB400MGCAPSULE / ORALAB2018-04-30d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204776-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204776-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204776-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204776-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204776-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204776-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204776-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204776-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204776-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204776-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204776-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204776-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204776-004AB1d06236e962d9…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBAmerican Health Packaging4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc72026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 60687-436
ndc (product): 60687-447
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBMicro Labs Limited408b30d6-f5c2-4239-b993-d8f77a8e160b2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 42571-143
ndc (product): 42571-145
ndc (product): 42571-142
ndc (product): 42571-144
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 71335-1804
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 71335-1066
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 80425-0040
CELECOXIBCELECOXIBProficient Rx LP1071fcb5-0e9f-4e30-8fb4-df76fd876fe82024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBBryant Ranch Prepack627abea5-e39a-4e4f-b1ab-4842ed8112e92024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
CELECOXIBCELECOXIBA-S Medication Solutions00e67d5e-df6f-4dfd-8c2d-a001c8a99af02023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776
ndc (product): 50090-4789
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204776
application number: ANDA204776

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 78 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-142CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-143CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-144CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
42571-145CELECOXIBCelecoxibMicro Labs LimitedANDACurrent
45865-970CELECOXIBCelecoxibmedsource pharmaceuticalsANDACurrent
50090-4789CELECOXIBCelecoxibA-S Medication SolutionsANDACurrent
50090-4789CELECOXIBCelecoxibA-S Medication SolutionsANDACurrent
50090-4789CELECOXIBCelecoxibA-S Medication SolutionsANDACurrent
50436-0144CELECOXIBCelecoxibUnit Dose ServicesANDACurrent
53002-2338CELECOXIBCelecoxibRPK Pharmaceuticals, Inc.ANDACurrent
60687-436CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
60687-436CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
60687-436CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
60687-447CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
60687-447CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
60687-447CELECOXIBCelecoxibAmerican Health PackagingANDACurrent
63629-8156CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
63629-8156CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
63629-8156CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
68071-4642CELECOXIBCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4642CELECOXIBCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4642CELECOXIBCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4642CELECOXIBCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7735CELECOXIBCelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7735CELECOXIBCelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7735CELECOXIBCelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2748CELECOXIBCelecoxibREMEDYREPACK INC.ANDACurrent
70518-2748CELECOXIBCelecoxibREMEDYREPACK INC.ANDACurrent
70518-2748CELECOXIBCelecoxibREMEDYREPACK INC.ANDACurrent
70518-3204CELECOXIBCelecoxibREMEDYREPACK INC.ANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-213CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-469CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-469CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-469CELECOXIBCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1066CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1066CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1066CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1066CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1066CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1804CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
71335-1804CELECOXIBCelecoxibBryant Ranch PrepackANDACurrent
80425-0040CelebrexCelecoxib 200mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0040CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0040CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0040CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent