FDA.reportPublic FDA data

Application 077516

Type
ANDA
Sponsor
STRIDES 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
A077516-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11
A077516-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11
A077516-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11

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 22:54:322026-06A077516-001AMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-002AMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2007-07-11a50c72e98297…
2026-08-01 22:54:322026-06A077516-003AMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2007-07-11a50c72e98297…

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 BESYLATEBryant Ranch Prepackcb3da88f-cee0-4c22-9760-a50edc8fc1402023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077516
application number: ANDA077516
ndc (product): 71335-1887

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8282AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8283AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8284AMLODIPINE BESYLATEAMLODIPINE BESYLATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42582-313AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
42582-314AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
42582-315AMLODIPINE BESYLATEAMLODIPINE BESYLATEBi-Coastal Pharma International LLCANDACurrent
55700-740AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuality Care Products, LLCANDACurrent
62980-506AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
62980-507AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
62980-508AMLODIPINE BESYLATEAMLODIPINE BESYLATEVivimed Labs LimitedANDACurrent
69150-113Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-113Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-114Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-114Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-115Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
69150-115Amlodipine BesylateAmlodipine BesylateBIOMES PHARMACEUTICALS LLCANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-146AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-147AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71093-148AMLODIPINE BESYLATEAMLODIPINE BESYLATEACI Healthcare USA, Inc.ANDACurrent
71335-1887AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch PrepackANDACurrent
71335-1887AMLODIPINE BESYLATEAMLODIPINE BESYLATEBryant Ranch PrepackANDACurrent