FDA.reportPublic FDA data

Application 078021

Type
ANDA
Sponsor
AUROBINDO PHARMA

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 1.

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
A078021-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-17
A078021-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-17
A078021-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078021-001AB
A078021-002AB
A078021-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078021-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORALAB2007-07-17a50c72e98297…
2026-08-01 22:54:322026-06A078021-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORALAB2007-07-17a50c72e98297…
2026-08-01 22:54:322026-06A078021-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORALAB2007-07-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078021-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078021-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078021-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEAurobindo Pharma Limitedb6f298ba-2d7e-4a3c-9edb-8b60aba716d62026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078021
application number: ANDA078021
ndc (product): 65862-102
ndc (product): 65862-101
ndc (product): 65862-103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-390Amlodipine BesylateAmlodipine BesylateRising Pharmaceuticals, Inc.ANDACurrent
64980-391Amlodipine BesylateAmlodipine BesylateRising Pharmaceuticals, Inc.ANDACurrent
64980-392Amlodipine BesylateAmlodipine BesylateRising Pharmaceuticals, Inc.ANDACurrent
65862-101Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-101Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-101Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-101Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-101Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-102Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-102Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-102Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-102Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-102Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-103Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-103Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-103Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-103Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent
65862-103Amlodipine BesylateAmlodipine BesylateAurobindo Pharma LimitedANDACurrent