Home Applications 020401 Application 020401
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG Yes No 002 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 180MG Yes No 003 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 240MG Yes No 004 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 300MG Yes No 005 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 360MG Yes No 006 TIAZAC DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 420MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020401-001 TIAZAC DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 N020401-002 TIAZAC DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 N020401-003 TIAZAC DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 N020401-004 TIAZAC DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 N020401-005 TIAZAC DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 N020401-006 TIAZAC DILTIAZEM HYDROCHLORIDE 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD, RS 1998-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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 7 of 7 · 264 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 2022-10-28 04:53 UTC 2022-10 N020401-001 TIAZAC 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020401-002 TIAZAC 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020401-003 TIAZAC 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020401-004 TIAZAC 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020401-005 TIAZAC 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020401-006 TIAZAC 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD, RS 1998-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020401-001 TIAZAC 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020401-002 TIAZAC 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020401-003 TIAZAC 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020401-004 TIAZAC 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020401-005 TIAZAC 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020401-006 TIAZAC 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD, RS 1998-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-001 TIAZAC 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-002 TIAZAC 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-003 TIAZAC 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-004 TIAZAC 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-005 TIAZAC 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020401-006 TIAZAC 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD, RS 1998-10-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-001 TIAZAC 120MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-002 TIAZAC 180MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-003 TIAZAC 240MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-004 TIAZAC 300MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-005 TIAZAC 360MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD 1995-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020401-006 TIAZAC 420MG CAPSULE, EXTENDED RELEASE / ORAL AB4 RLD, RS 1998-10-16 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 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 · 5 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 · 81 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-2612 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2612 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2612 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2612 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 0187-2613 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2613 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2613 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2613 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 0187-2614 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2614 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2614 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2614 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 0187-2615 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2615 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2615 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2615 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 0187-2616 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2616 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2616 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2616 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 0187-2617 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2617 TIAZAC diltiazem hydrochloride Bausch Health Americas, Inc. NDA Current 0187-2617 TIAZAC diltiazem hydrochloride Bausch Health US LLC NDA Current 0187-2617 TIAZAC diltiazem hydrochloride Valeant Pharmaceuticals North America LLC NDA Current 24658-170 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-170 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-171 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-171 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-172 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-172 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-173 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-173 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-174 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-174 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-346 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 24658-346 Diltiazem Hydrochloride Diltiazem Hydrochloride PuraCap Laboratories LLC NDA AUTHORIZED GENERIC Current 43353-888 diltiazem hydrochloride diltiazem hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-889 diltiazem hydrochloride diltiazem hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-903 diltiazem hydrochloride diltiazem hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-906 diltiazem hydrochloride diltiazem hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 43353-907 diltiazem hydrochloride diltiazem hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 63629-4335 diltiazem hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-7981 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-7981 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-7981 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 68071-3199 Diltiazem Hydrochloride diltiazem hydrochloride NuCare Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 68071-3398 Diltiazem Hydrochloride diltiazem hydrochloride NuCare Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 68151-1480 diltiazem hydrochloride diltiazem hydrochloride Carilion Materials Management NDA AUTHORIZED GENERIC Current 68151-2111 diltiazem hydrochloride diltiazem hydrochloride Carilion Materials Management NDA AUTHORIZED GENERIC Current 68151-2112 diltiazem hydrochloride diltiazem hydrochloride Carilion Materials Management NDA AUTHORIZED GENERIC Current 68151-2113 diltiazem hydrochloride diltiazem hydrochloride Carilion Materials Management NDA AUTHORIZED GENERIC Current 68151-2114 diltiazem hydrochloride diltiazem hydrochloride Carilion Materials Management NDA AUTHORIZED GENERIC Current 68682-367 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-367 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-367 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-368 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-368 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-368 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-369 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-369 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-369 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-370 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-370 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-370 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-371 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-371 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-371 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-372 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-372 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-372 Diltiazem Hydrochloride diltiazem hydrochloride Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 70518-1009 Diltiazem Hydrochloride diltiazem hydrochloride REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1009 Diltiazem Hydrochloride diltiazem hydrochloride REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1993 Diltiazem Hydrochloride diltiazem hydrochloride REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 70518-1993 Diltiazem Hydrochloride diltiazem hydrochloride REMEDYREPACK INC. NDA AUTHORIZED GENERIC Current 71335-0839 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-0839 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-0839 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-0839 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-1585 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 71335-1585 Diltiazem Hydrochloride diltiazem hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 82018 SUPPL 2025-04-28 81954 SUPPL 2025-04-24 45915 SUPPL 2016-11-22 45939 SUPPL 2016-11-21 24906 SUPPL 2010-11-30 34601 SUPPL 2010-11-22 2476 SUPPL 2007-07-05 41336 SUPPL 2001-12-04 20632 SUPPL 2001-06-06 41335 SUPPL 1998-01-30