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
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.786e8ad3-a8d7-41e6-e053-2991aa0a32c72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAurobindo Pharma Limited7cc14b86-0833-4c3c-91f3-7963d7052fd52024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 65862-145
ndc (product): 65862-144
ndc (product): 65862-142
ndc (product): 65862-143
CarvedilolCARVEDILOLProficient Rx LPcd7e7c34-6958-47be-a1c1-f1ed948e26872022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 63187-409
ndc (product): 63187-447
CarvedilolCARVEDILOLProficient Rx LP36230cc8-e808-4f74-a27d-4367eecd21f72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 63187-946
CarvedilolCARVEDILOLProficient Rx LP55a19ff1-f8c1-4cf0-8711-9bfa32756de92020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 63187-941
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCd0089df4-37c8-41de-810c-14c9dc06f0c32018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332

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 3 · 220 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53002-1574CarvedilolCarvedilolRPK Pharmaceuticals, Inc.ANDACurrent
53808-0687CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
53808-0815CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
53808-0820CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
53808-0859CarvedilolCarvedilolState of Florida DOH Central PharmacyANDACurrent
60760-143CARVEDILOLCARVEDILOLSt Marys Medical Park PharmacyANDACurrent
60760-144CARVEDILOLCARVEDILOLSt Marys Medical Park PharmacyANDACurrent
60760-145CARVEDILOLCARVEDILOLSt Marys Medical Park PharmacyANDACurrent
60760-233CarvedilolCarvedilolSt. Mary's Medical Park PharmacyANDACurrent
60760-234CarvedilolCarvedilolSt. Mary's Medical Park PharmacyANDACurrent
60760-235CarvedilolCarvedilolSt. Mary's Medical Park PharmacyANDACurrent
61919-219CarvedilolCarvedilolDirect_RxANDACurrent
61919-219CarvedilolCarvedilolDirect_RxANDACurrent
61919-219CarvedilolCarvedilolDirect_RxANDACurrent
61919-728CarvedilolCarvedilolDirect_RxANDACurrent
61919-728CarvedilolCarvedilolDirect_RxANDACurrent
61919-728CarvedilolCarvedilolDirect_RxANDACurrent
61919-730CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
61919-730CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-730CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-730CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-730CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-984CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
61919-984CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-984CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-984CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-984CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
61919-984CARVEDILOLCARVEDILOLDirect_RxANDACurrent
61919-984CARVEDILOLCARVEDILOLDIRECT RXANDACurrent
63187-409CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-409CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-409CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-409CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-447CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-447CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-447CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-447CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-941CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-941CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-941CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-946CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-946CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-946CarvedilolCarvedilolProficient Rx LPANDACurrent
63187-946CarvedilolCarvedilolProficient Rx LPANDACurrent
63629-3668CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-3669CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6424CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6424CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6424CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6435CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6435CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6435CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6453CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6453CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6511CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-6511CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-8221CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-8221CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
63629-8221CarvedilolCarvedilolBryant Ranch PrepackANDACurrent
65862-142CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-142CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-142CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-142CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-142CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-143CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-143CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-143CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-143CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-143CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-144CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-144CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-144CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-144CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-144CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-145CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-145CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-145CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-145CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
65862-145CarvedilolCarvedilolAurobindo Pharma LimitedANDACurrent
68071-1901CarvedilolCarvedilolNuCare Pharmaceuticals, Inc.ANDACurrent

Documents#

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