Application 077614

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARVEDILOLCARVEDILOLTABLET;ORAL6.25MGNoNo
002CARVEDILOLCARVEDILOLTABLET;ORAL12.5MGNoNo
003CARVEDILOLCARVEDILOLTABLET;ORAL25MGNoNo
004CARVEDILOLCARVEDILOLTABLET;ORAL3.125MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077614-001CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A077614-002CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A077614-003CARVEDILOLCARVEDILOL25MGTABLET / ORALAB2007-09-05
A077614-004CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077614-001AB
A077614-002AB
A077614-003AB
A077614-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05c2088c7a36db…
2026-10-15 13:18:302026-09A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05c2088c7a36db…
2026-10-15 13:18:302026-09A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05c2088c7a36db…
2026-10-15 13:18:302026-09A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05c2088c7a36db…
2026-09-14 22:38:342026-08A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077614-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077614-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077614-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077614-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077614-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077614-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077614-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077614-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-004AB12680178bc6a6…

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 2 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLA-S Medication Solutions3eb4fd8e-1027-4d24-8f2f-12e9dcfe62312026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutionsadd1ee3d-fca4-4301-b871-7dda6eda7bb72026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutions3724c7f1-dd2a-4bc9-b388-17238d6638602026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutions157f64c6-2c21-4056-b643-79047ca237a92026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.444ee05c-571a-4ea6-8763-af05d252df562026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutionsf0617fa4-1e87-48fa-947a-e4249153a9472026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutionsdd8b2a3f-c2fa-4859-84a1-c02f2b6087482026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLQuallent Pharmaceuticals Health LLCeb892787-edd0-4ab6-aef2-2d02163843952026-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLNorthwind Health Company, LLCb0887c72-bc6a-010d-e053-2995a90aab8d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLZydus Pharmaceuticals USA Inc.dc6a2d33-aa04-4a04-9cde-901b744d24ca2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLZydus Lifesciences Limited29082d8c-bbde-4620-924f-02dcf17649192025-12-31Exact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLNorthwind Health Company, LLCa570b8ea-530d-4565-a091-bb9dbe4a6d8d2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLNorthwind Health Company, LLCdf600dde-8ef9-52e3-e053-2a95a90a2dc02025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLNorthwind Health Company, LLCf2a0407c-2e05-60eb-e053-2a95a90abc992025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutionsed60e2e4-6eda-4728-aec4-263b821e4ed82025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLProficient Rx LPd5822e3c-413c-4c7e-bbec-d0d42d2028ba2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutions64ba2b17-989e-443c-8277-9649489b5ce82025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLAmerican Health Packaginga97a2467-7525-467c-8969-38246903690c2025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLPreferred Pharmaceuticals,Inc.81bc612d-5674-45b9-a1f5-2cb4fa6257472025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
ndc (product): 68788-9265
ndc (product): 68788-9789
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.ac14846e-423a-37c4-e053-2a95a90a3cdd2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 144 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68645-351CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-496CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-496CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-496CarvedilolCarvedilolLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7539CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7539CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7539CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7539CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8252CarvedilolCarvedilolPreferred Pharmaceuticals Inc.ANDACurrent
68788-9265CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9265CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9265CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9265CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9265CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9789CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9789CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9789CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9789CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
68788-9789CarvedilolCarvedilolPreferred Pharmaceuticals,Inc.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0356CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0426CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0582CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0582CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0582CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0582CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0582CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0840CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0840CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0840CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1377CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1826CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1826CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1826CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1826CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-2389CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-2389CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-2389CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70934-211CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-211CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-211CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-759CarvedilolCarvedilolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-759CarvedilolCarvedilolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1545CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1545CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-1623CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-2101CarvedilolCarvedilolBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31265ORIG2007-09-07