Home Applications 077169 Application 077169
Type ANDA
Sponsor ELITE LABS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISRADIPINE ISRADIPINE CAPSULE;ORAL 2.5MG No No 002 ISRADIPINE ISRADIPINE CAPSULE;ORAL 5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077169-001 ISRADIPINE ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 A077169-002 ISRADIPINE ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077169-001 ISRADIPINE 2.5MG CAPSULE / ORAL AB 2006-04-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A077169-002 ISRADIPINE 5MG CAPSULE / ORAL AB 2006-04-24 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42806-263 Isradipine Isradipine Epic Pharma, LLC ANDA Current 42806-263 Isradipine Isradipine Epic Pharma, LLC ANDA Current 42806-264 Isradipine Isradipine Epic Pharma, LLC ANDA Current 42806-264 Isradipine Isradipine Epic Pharma, LLC ANDA Current 60429-385 Isradipine Isradipine Golden State Medical Supply, Inc. ANDA Current 60429-385 Isradipine Isradipine Golden State Medical Supply, Inc. ANDA Current 60429-386 Isradipine Isradipine Golden State Medical Supply, Inc. ANDA Current 60429-386 Isradipine Isradipine Golden State Medical Supply, Inc. ANDA Current 64850-910 Isradipine Isradipine Elite Laboratories, Inc. ANDA Current 64850-911 Isradipine Isradipine Elite Laboratories, Inc. ANDA Current 68462-807 Isradipine Isradipine Glenmark Pharmaceuticals Inc.,USA ANDA Current 68462-807 Isradipine Isradipine Glenmark Pharmaceuticals Inc.,USA ANDA Current 68462-808 Isradipine Isradipine Glenmark Pharmaceuticals Inc.,USA ANDA Current 68462-808 Isradipine Isradipine Glenmark Pharmaceuticals Inc.,USA ANDA Current