Home Applications 078710 Application 078710
Type ANDA
Sponsor CIPLA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TELMISARTAN TELMISARTAN TABLET;ORAL 20MG No No 002 TELMISARTAN TELMISARTAN TABLET;ORAL 40MG No No 003 TELMISARTAN TELMISARTAN TABLET;ORAL 80MG 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 A078710-001 TELMISARTAN TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 A078710-002 TELMISARTAN TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 A078710-003 TELMISARTAN TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08
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 · 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 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-002 TELMISARTAN 40MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078710-003 TELMISARTAN 80MG TABLET / ORAL AB 2014-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078710-001 TELMISARTAN 20MG TABLET / ORAL AB 2014-01-08 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TELMISARTAN TELMISARTAN Chartwell RX, LLC. beaaf383-730f-4411-b5e7-15c32b53a338 2025-12-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078710 application number: ANDA078710
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-3293 Telmisartan Telmisartan Actavis Pharma, Inc. ANDA Current 0591-3294 Telmisartan Telmisartan Actavis Pharma, Inc. ANDA Current 72606-506 Telmisartan Telmisartan CELLTRION USA, INC. ANDA Current 72606-507 Telmisartan Telmisartan CELLTRION USA, INC. ANDA Current 72606-508 Telmisartan Telmisartan CELLTRION USA, INC. ANDA Current