Application 078332

Type
ANDA
Sponsor
AUROBINDO PHARMA

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
A078332-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078332-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078332-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078332-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078332-001AB
A078332-002AB
A078332-003AB
A078332-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078332-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078332-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078332-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078332-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A078332-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004AB15bbf6a4d5a75…

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
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.0930965b-80e3-4a0c-bffc-14ac32a478942025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.2be8635b-5733-1ed4-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.8640adde-d071-44a4-97d0-fa8a8548debe2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.205da5d0-05d9-440d-bb5a-b30b826900ab2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLA-S Medication Solutionsf5969d18-46c7-4f35-9668-2fd4f6bbeb172025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLBryant Ranch Prepackfe4aa7f0-6ef2-4a95-8a64-5e3365f104742024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 71335-0273
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.786e8ad3-a8d7-41e6-e053-2991aa0a32c72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 68071-4600
CarvedilolCARVEDILOLAurobindo Pharma Limited7cc14b86-0833-4c3c-91f3-7963d7052fd52024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LPcd7e7c34-6958-47be-a1c1-f1ed948e26872022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP36230cc8-e808-4f74-a27d-4367eecd21f72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP55a19ff1-f8c1-4cf0-8711-9bfa32756de92020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCd0089df4-37c8-41de-810c-14c9dc06f0c32018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 71610-132

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 3 of 3 · 220 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-1935CarvedilolCarvedilolNuCare Pharmaceutical, Inc.ANDACurrent
68071-1954CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1962CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3026CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3078CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3078CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3151CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3151CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3269CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3269CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4470CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4470CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4470CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4495CarvedilolCarvedilolNuCare Pharmaceuticals,InANDACurrent
68071-4495CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4495CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4600CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4600CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4974CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4974CarvedilolCarvedilolNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6817CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6817CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6817CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6817CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6819CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6819CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6819CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-6819CarvedilolCarvedilolPreferred Pharmaceuticals, IncANDACurrent
68788-9691CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9738CarvedilolCarvedilolPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0123CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0123CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0123CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0169CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0169CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-0169CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1355CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70518-1355CarvedilolCarvedilolREMEDYREPACK INC.ANDACurrent
70786-0144CarvedilolCarvedilolUnit Dose ServicesANDACurrent
70934-406CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-406CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-515CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-516CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-517CarvedilolCarvedilolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0034CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0034CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0034CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0034CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0273CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0273CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0273CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0368CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0368CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0368CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0368CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0561CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0561CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0561CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71335-0561CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
71610-132CarvedilolCarvedilolAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9144ORIG2007-09-07