Application 207446

Type
ANDA
Sponsor
CIPLA

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
A207446-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2015-09-23
A207446-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2015-09-23
A207446-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2015-09-23
A207446-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207446-001AB
A207446-002AB
A207446-003AB
A207446-004AB

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 UTC2026-02A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207446-001CELECOXIB50MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-002CELECOXIB100MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-003CELECOXIB200MGCAPSULE / ORALAB2015-09-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-004CELECOXIB400MGCAPSULE / ORALAB2015-09-23d06236e962d9…

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 UTC2026-02A207446-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207446-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207446-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207446-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207446-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207446-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207446-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207446-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207446-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207446-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207446-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207446-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207446-004AB1d06236e962d9…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 70518-2233
CELECOXIBCELECOXIBNorthwind Health Company, LLCf874eddf-b2f3-6830-e053-6394a90ade7a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBNorthwind Health Company, LLCf2a0db9f-174b-1603-e053-2995a90a79a32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBA-S Medication Solutions95b2ced1-eca2-4c25-aa10-c9fb86b353a32025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBA-S Medication Solutions7b8e923c-253f-461e-94d7-669e75dc73e92025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.3191c9dc-bfdf-0591-e054-00144ff8d46c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 43063-669
CELECOXIBCELECOXIBQuallent Pharmaceuticals Health LLCaaa3a4f5-b281-415f-a08c-e0cefdae2fb52025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
CELECOXIBCELECOXIBCipla USA Inc.d12625b1-2af9-4532-af91-d40b65eeffef2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 69097-422
ndc (product): 69097-423
ndc (product): 69097-421
ndc (product): 69097-420
CELECOXIBCELECOXIBNorthStar RxLLCce61a585-5ac0-4185-99eb-a9511cd25a982025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 16714-732
ndc (product): 16714-733
ndc (product): 16714-734
ndc (product): 16714-731
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9d962a-5469-2039-e053-2a95a90ad59f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 80425-0039
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc1abc73e-c6ab-a0a5-e053-2a95a90a08172024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 80425-0142
CELECOXIBCELECOXIBProficient Rx LPc91e5933-1798-4096-9f08-fb1200e154e12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207446
application number: ANDA207446
ndc (product): 63187-301

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2394CELECOXIBCELECOXIBA-S Medication SolutionsANDACurrent
55700-449CELECOXIBCELECOXIBLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-450CELECOXIBCELECOXIBLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-301CELECOXIBCELECOXIBProficient Rx LPANDACurrent
63187-301CELECOXIBCELECOXIBProficient Rx LPANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
68788-6393CELECOXIBCELECOXIBPreferred Pharmaceuticals Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
70518-2233CELECOXIBCELECOXIBREMEDYREPACK INC.ANDACurrent
70934-978CELECOXIBCELECOXIBDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-978CELECOXIBCELECOXIBDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0450CELECOXIBCELECOXIBBryant Ranch PrepackANDACurrent
76282-692CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-693CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-694CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-695CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
80425-0039CelebrexCelecoxib 200mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0039CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0039CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelebrexCelecoxib 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelebrexCelecoxib 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent