Home Applications 203245 Application 203245
Type ANDA
Sponsor UNICHEM LABS LTD 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 43 .
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 A203245-001 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 A203245-002 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 A203245-003 AMLODIPINE BESYLATE AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 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 2026-09-14 22:38:34 2026-08 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-002 AMLODIPINE BESYLATE EQ 5MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203245-003 AMLODIPINE BESYLATE EQ 10MG BASE TABLET / ORAL AB 2013-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203245-001 AMLODIPINE BESYLATE EQ 2.5MG BASE TABLET / ORAL AB 2013-10-21 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 2 of 2 · 21 matching rows.
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 1 of 2 · 129 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0179-0210 Amlodipine Besylate Amlodipine Besylate KAISER FOUNDATION HOSPITALS ANDA Current 0179-0211 Amlodipine Besylate Amlodipine Besylate KAISER FOUNDATION HOSPITALS ANDA Current 0179-0213 Amlodipine Besylate Amlodipine Besylate KAISER FOUNDATION HOSPITALS ANDA Current 0615-8199 Amlodipine Besylate Amlodipine Besylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8200 Amlodipine Besylate Amlodipine Besylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8201 Amlodipine Besylate Amlodipine Besylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 12634-562 Amlodipine Besylate Amlodipine Besylate Apotheca Inc. ANDA Current 12634-599 Amlodipine Besylate Amlodipine Besylate Apotheca Inc. ANDA Current 29300-241 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-241 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-241 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-241 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-242 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-242 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-242 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-242 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-243 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-243 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-243 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-243 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-396 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-396 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-396 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-396 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-397 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-397 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-397 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-397 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-398 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-398 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-398 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 29300-398 Amlodipine Besylate Amlodipine Besylate Unichem Pharmaceuticals (USA), Inc. ANDA Current 45865-617 Amlodipine Besylate Amlodipine Besylate Medsource Pharmaceuticals ANDA Current 50090-1404 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1404 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1404 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1404 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1527 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1527 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1527 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1529 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1529 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-1529 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 50090-4903 Amlodipine Besylate Amlodipine Besylate A-S Medication Solutions ANDA Current 51655-052 Amlodipine Besylate Amlodipine Besylate Northwind Pharmaceuticals ANDA Current 51655-052 Amlodipine Besylate Amlodipine Besylate Northwind Pharmaceuticals ANDA Current 53002-2249 Amlodipine Besylate Amlodipine Besylate RPK Pharmaceuticals, Inc. ANDA Current 53002-2249 Amlodipine Besylate Amlodipine Besylate RPK Pharmaceuticals, Inc. ANDA Current 53002-2351 Amlodipine Besylate Amlodipine Besylate RPK Pharmaceuticals, Inc. ANDA Current 53002-2351 Amlodipine Besylate Amlodipine Besylate RPK Pharmaceuticals, Inc. ANDA Current 53002-3249 Amlodipine Besylate Amlodipine Besylate RPK Pharmaceuticals, Inc. ANDA Current 60760-445 Amlodipine Besylate Amlodipine Besylate St. Mary's Medical Park Pharmacy ANDA Current 60760-459 Amlodipine Besylate Amlodipine Besylate St. Mary's Medical Park Pharmacy ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Direct_Rx ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Direct_Rx ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-782 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DIRECT RX ANDA Current 61919-844 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DirectRX ANDA Current 61919-844 AMLODIPINE BESYLATE AMLODIPINE BESYLATE Direct_Rx ANDA Current 61919-844 AMLODIPINE BESYLATE AMLODIPINE BESYLATE DirectRX ANDA Current 63187-326 Amlodipine Besylate Amlodipine Besylate Proficient Rx LP ANDA Current 63187-326 Amlodipine Besylate Amlodipine Besylate Proficient Rx LP ANDA Current 63187-508 Amlodipine Besylate Amlodipine Besylate Proficient Rx LP ANDA Current 63187-508 Amlodipine Besylate Amlodipine Besylate Proficient Rx LP ANDA Current 63187-508 Amlodipine Besylate Amlodipine Besylate Proficient Rx LP ANDA Current 63629-8023 Amlodipine Besylate Amlodipine Besylate Bryant Ranch Prepack ANDA Current 63629-8023 Amlodipine Besylate Amlodipine Besylate Bryant Ranch Prepack ANDA Current 63629-8023 Amlodipine Besylate Amlodipine Besylate Bryant Ranch Prepack ANDA Current 63629-8024 Amlodipine Besylate Amlodipine Besylate Bryant Ranch Prepack ANDA Current 63629-8024 Amlodipine Besylate Amlodipine Besylate Bryant Ranch Prepack ANDA Current 67296-1529 Amlodipine Besylate Amlodipine Besylate RedPharm Drug, Inc. ANDA Current 67296-1529 Amlodipine Besylate Amlodipine Besylate RedPharm Drug, Inc. ANDA Current 67296-1529 Amlodipine Besylate Amlodipine Besylate RedPharm Drug, Inc. ANDA Current