Application 077316

Type
ANDA
Sponsor
MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077316-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORAL2007-09-05
A077316-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORAL2007-09-05
A077316-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORAL2007-09-05
A077316-004CARVEDILOLCARVEDILOL25MGTABLET / ORAL2007-09-05

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077316-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077316-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077316-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077316-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077316-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077316-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077316-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077316-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077316-003AB15d02ea3f76ae…

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 4 of 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLNorthwind Health Company, LLCc133b9c7-ab1a-e517-e053-2995a90a517a2026-01-01Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLNorthwind Health Company, LLCdb5d9e64-46b3-92d3-e053-2995a90a74bc2026-01-01Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLZydus Pharmaceuticals USA Inc.dc6a2d33-aa04-4a04-9cde-901b744d24ca2026-01-01Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLZydus Lifesciences Limited29082d8c-bbde-4620-924f-02dcf17649192025-12-31Name fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLNorthwind Health Company, LLCa570b8ea-530d-4565-a091-bb9dbe4a6d8d2025-12-26Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLNorthwind Health Company, LLCdf600dde-8ef9-52e3-e053-2a95a90a2dc02025-12-26Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLNorthwind Health Company, LLCf2a0407c-2e05-60eb-e053-2a95a90abc992025-12-26Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLDirect_Rx462a9678-d2cd-d2b8-e063-6294a90a01392025-12-17Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLQPharma, Inc.ffbedcce-0d64-4aed-9e65-09448d71ca912025-12-05Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLA-S Medication Solutionsed60e2e4-6eda-4728-aec4-263b821e4ed82025-12-02Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLProficient Rx LP52785a22-ddca-4f5b-8579-5974df2a9a4e2025-12-01Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLProficient Rx LPd5822e3c-413c-4c7e-bbec-d0d42d2028ba2025-12-01Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLCoupler LLC441dda59-c3c4-d3c6-e063-6394a90a98dc2025-11-21Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLGlenmark Pharmaceuticals Inc., USAc4a21f67-7812-4634-beba-f8e85c63c5f22025-10-27Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLMethod Pharmaceuticals, LLCa6ab5da0-8f22-491d-b007-85d9d49018282025-10-21Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.0930965b-80e3-4a0c-bffc-14ac32a478942025-10-17Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.2be8635b-5733-1ed4-e054-00144ff88e882025-10-15Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.8640adde-d071-44a4-97d0-fa8a8548debe2025-10-15Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.205da5d0-05d9-440d-bb5a-b30b826900ab2025-10-15Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL
CarvedilolCARVEDILOLA-S Medication Solutions64ba2b17-989e-443c-8277-9649489b5ce82025-08-26Warnings, Adverse reactionsName fallback
brand name: Carvedilol
generic name: CARVEDILOL

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 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3631CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3632CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3633CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
0378-3634CarvedilolcarvedilolMylan Pharmaceuticals Inc.ANDACurrent
43353-132CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-133CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-156CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-160CarvedilolcarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-771CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-930CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-931CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51079-932CarvedilolcarvedilolMylan Institutional Inc.ANDACurrent
51655-002CarvedilolCarvedilolNorthwind PharmaceuticalsANDACurrent
55154-5675CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5675CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5676CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5677CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal Health 107, LLCANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent
55154-5678CarvedilolcarvedilolCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31222ORIG2007-09-07