Application 078043

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASENoNo
002AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASENoNo
003AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078043-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12
A078043-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12
A078043-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078043-001AB
A078043-002AB
A078043-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALBX2007-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078043-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-121e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078043-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078043-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078043-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078043-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078043-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078043-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078043-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078043-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078043-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078043-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-002BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078043-003BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-002BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078043-003BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-002BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078043-003BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078043-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-002BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078043-003BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-002BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078043-003BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-002BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078043-003BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078043-001AB11e350fbaab3a…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATELupin Pharmaceuticals, Inc.003dd1ec-16f8-4f96-b6a8-c4689d35892a2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
ndc (product): 68180-750
ndc (product): 68180-720
ndc (product): 68180-751
ndc (product): 68180-721
ndc (product): 68180-752
ndc (product): 68180-719
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.1df35c9b-0cd8-41f4-b9d4-8f51ba57b3e02026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEPreferred Pharmaceuticals Inc.a6635bb3-b8d5-4046-ac56-27af9bac877e2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.2437a130-d544-6db4-e063-6394a90a0d4d2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPf18148f9-42b2-43dc-9cf8-212d9121dc5f2024-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions91e11ca6-05fb-47be-bd40-f8649a35d47d2024-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
ndc (product): 50090-5355
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions3bd019d3-b58c-44ab-9190-606a0af5e9b62024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043
ndc (product): 50090-5354
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack49d69d27-2a75-4a07-bfb9-24f8af8531382024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078043
application number: ANDA078043

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5354Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-5354Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-5354Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-5355Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
50090-5355Amlodipine BesylateAmlodipine BesylateA-S Medication SolutionsANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-719Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-720Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-721Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-750Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-751Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
68180-752Amlodipine BesylateAmlodipine BesylateLupin Pharmaceuticals, Inc.ANDACurrent
70518-1597Amlodipine BesylateAmlodipine BesylateREMEDYREPACK INC.ANDACurrent
70518-1597Amlodipine BesylateAmlodipine BesylateREMEDYREPACK INC.ANDACurrent
70518-1914Amlodipine BesylateAmlodipine BesylateREMEDYREPACK INC.ANDACurrent
70518-1914Amlodipine BesylateAmlodipine BesylateREMEDYREPACK INC.ANDACurrent
70518-1914Amlodipine BesylateAmlodipine BesylateREMEDYREPACK INC.ANDACurrent