Home Applications 020591 Application 020591
Type NDA
Sponsor ABBVIE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2MG;180MG Yes No 002 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 4MG;240MG Yes Yes 003 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1MG;240MG Yes No 004 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 2MG;240MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020591-001 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;180MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 N020591-002 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 4MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 N020591-003 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 N020591-004 TARKA TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE 2MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22
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 5 of 5 · 176 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 N020591-001 TARKA 2MG;180MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020591-002 TARKA 4MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020591-003 TARKA 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020591-004 TARKA 2MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020591-001 TARKA 2MG;180MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020591-002 TARKA 4MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020591-003 TARKA 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020591-004 TARKA 2MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020591-001 TARKA 2MG;180MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020591-002 TARKA 4MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020591-003 TARKA 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020591-004 TARKA 2MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020591-001 TARKA 2MG;180MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020591-002 TARKA 4MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020591-003 TARKA 1MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020591-004 TARKA 2MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD 1996-10-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-3287 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3287 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3287 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3289 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3289 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3289 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3290 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3290 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 0074-3290 Tarka Trandolapril and Verapamil Hydrochloride AbbVie Inc. NDA Current 59762-0122 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0122 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0122 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0122 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0132 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0132 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0132 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0132 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0142 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0142 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0142 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current 59762-0142 Trandolapril and Verapamil Hydrochloride Trandolapril and Verapamil Hydrochloride Greenstone LLC NDA Current