Home Applications 017963 Application 017963
Type NDA
Sponsor US PHARMS HOLDINGS I Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPRESSOR METOPROLOL TARTRATE TABLET;ORAL 50MG Yes No 002 LOPRESSOR METOPROLOL TARTRATE TABLET;ORAL 100MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N017963-001 LOPRESSOR METOPROLOL TARTRATE 50MG TABLET / ORAL AB RLD, Approved before 1982 N017963-002 LOPRESSOR METOPROLOL TARTRATE 100MG TABLET / ORAL AB RLD, Approved before 1982
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 3 of 3 · 88 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 N017963-001 LOPRESSOR 50MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N017963-002 LOPRESSOR 100MG TABLET / ORAL AB RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017963-001 LOPRESSOR 50MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N017963-002 LOPRESSOR 100MG TABLET / ORAL AB RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017963-001 LOPRESSOR 50MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017963-002 LOPRESSOR 100MG TABLET / ORAL AB RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017963-001 LOPRESSOR 50MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017963-002 LOPRESSOR 100MG TABLET / ORAL AB RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30698-458 Lopressor metoprolol tartrate Validus Pharmaceuticals LLC NDA Current 30698-458 Lopressor metoprolol tartrate Validus Pharmaceuticals LLC NDA Current 30698-459 Lopressor metoprolol tartrate Validus Pharmaceuticals LLC NDA Current 30698-459 Lopressor metoprolol tartrate Validus Pharmaceuticals LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77141 SUPPL 2024-01-04 77175 SUPPL 2024-01-03 74711 SUPPL 2023-07-07 74705 SUPPL 2023-07-06 13967 SUPPL 2013-03-15 11100 SUPPL 2013-03-15 11099 SUPPL 2013-01-11 761 SUPPL 2012-12-26 33379 SUPPL 2011-03-21 760 SUPPL 2010-01-06 33378 SUPPL 2009-11-23 759 SUPPL 2008-07-30 33377 SUPPL 2008-07-29 13966 SUPPL 2008-01-09 758 SUPPL 2006-09-18 13965 SUPPL 2003-09-25