Application 019668

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARDURADOXAZOSIN MESYLATETABLET;ORALEQ 1MG BASEYesYes
002CARDURADOXAZOSIN MESYLATETABLET;ORALEQ 2MG BASEYesNo
003CARDURADOXAZOSIN MESYLATETABLET;ORALEQ 4MG BASEYesNo
004CARDURADOXAZOSIN MESYLATETABLET;ORALEQ 8MG BASEYesNo

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
N019668-001CARDURADOXAZOSIN MESYLATEEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02
N019668-002CARDURADOXAZOSIN MESYLATEEQ 2MG BASETABLET / ORALABRLD1990-11-02
N019668-003CARDURADOXAZOSIN MESYLATEEQ 4MG BASETABLET / ORALABRLD1990-11-02
N019668-004CARDURADOXAZOSIN MESYLATEEQ 8MG BASETABLET / ORALABRLD1990-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019668-001AB
N019668-002AB
N019668-003AB
N019668-004AB

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 UTC2026-02N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019668-001CARDURAEQ 1MG BASETABLET / ORALABRLD, RS1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-002CARDURAEQ 2MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-003CARDURAEQ 4MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-004CARDURAEQ 8MG BASETABLET / ORALABRLD1990-11-02d06236e962d9…

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 UTC2026-02N019668-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019668-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019668-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019668-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019668-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019668-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019668-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019668-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019668-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019668-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019668-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019668-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019668-004AB1d06236e962d9…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxazosin mesylateDOXAZOSIN MESYLATEAphena Pharma Solutions - Tennessee, LLC445dc831-1960-4b25-e063-6294a90a6efd2025-11-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLC3ab222b7-74cc-5343-e063-6294a90a96162025-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
Doxazosin mesylateDOXAZOSIN MESYLATEMylan Pharmaceuticals Inc.2e524986-7903-416f-b2b8-d27295103e752024-03-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
CarduraDOXAZOSINViatris Specialty LLC5e1f5e49-2da1-43ab-9795-228a8bcc5a822023-10-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINAphena Pharma Solutions - Tennessee, LLCb364c7a8-72b5-4776-a500-400c37a72c9b2022-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
DoxazosinDOXAZOSINMylan Pharmaceuticals Inc.6b887aa5-5edf-48c5-a480-dea8c35afa9d2022-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
ndc (product): 59762-2380
ndc (product): 59762-2310
ndc (product): 59762-2320
ndc (product): 59762-2410
ndc (product): 59762-2340
CarduraDOXAZOSINROERIGeefc47bc-c10f-49bb-8ef7-5999f798ab392022-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019668
application number: NDA019668
ndc (product): 0049-2750
ndc (product): 0049-2512
ndc (product): 0049-2770
ndc (product): 0049-2760
ndc (product): 0049-2780
ndc (product): 0049-2410
ndc (product): 0049-2614

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-2410CarduradoxazosinRoerigNDACurrent
0049-2410CarduradoxazosinRoerigNDACurrent
0049-2410CarduradoxazosinRoerigNDACurrent
0049-2512CarduradoxazosinRoerigNDACurrent
0049-2512CarduradoxazosinRoerigNDACurrent
0049-2512CarduradoxazosinRoerigNDACurrent
0049-2614CarduradoxazosinRoerigNDACurrent
0049-2614CarduradoxazosinRoerigNDACurrent
0049-2614CarduradoxazosinRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2750Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2760Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2770Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
0049-2780Carduradoxazosin mesylateRoerigNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2310Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2320Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2340Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2380Doxazosin mesylatedoxazosin mesylateGreenstone LLCNDACurrent
59762-2410DoxazosindoxazosinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2410DoxazosindoxazosinGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-2410DoxazosindoxazosinGreenstone LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68463SUPPL2021-08-25
67895SUPPL2021-06-24
11617SUPPL2016-06-13
1482SUPPL2016-06-10
11615SUPPL2015-08-24
11616SUPPL2013-11-08
17541SUPPL2013-11-07
17540SUPPL2010-03-10
33850SUPPL2009-07-23
17539SUPPL2009-07-17
1481SUPPL2006-03-03
17538SUPPL2003-06-22
1480SUPPL2002-01-23