Home Applications 077516 Application 077516
Type ANDA
Sponsor STRIDES PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 2.5MG BASE No No 002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 5MG BASE No No 003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE TABLET;ORAL EQ 10MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077516-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 A077516-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 A077516-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11
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.
Product history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL 2007-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077516-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2007-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077516-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2007-07-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 39 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-8282 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8282 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8282 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8283 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8283 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8283 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8284 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8284 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8284 AMLODIPINE BESYLATE AMLODIPINE BESYLATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 42582-313 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Bi-Coastal Pharma International LLC ANDA Current 42582-314 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Bi-Coastal Pharma International LLC ANDA Current 42582-315 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Bi-Coastal Pharma International LLC ANDA Current 55700-740 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Quality Care Products, LLC ANDA Current 62980-506 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Vivimed Labs Limited ANDA Current 62980-507 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Vivimed Labs Limited ANDA Current 62980-508 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Vivimed Labs Limited ANDA Current 69150-113 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 69150-113 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 69150-114 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 69150-114 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 69150-115 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 69150-115 Amlodipine Besylate Amlodipine Besylate BIOMES PHARMACEUTICALS LLC ANDA Current 71093-146 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-146 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-146 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-146 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-146 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-147 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-147 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-147 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-147 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-147 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-148 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-148 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-148 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-148 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71093-148 AMLODIPINE BESYLATE AMLODIPINE BESYLATE ACI Healthcare USA, Inc. ANDA Current 71335-1887 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Bryant Ranch Prepack ANDA Current 71335-1887 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Bryant Ranch Prepack ANDA Current