Home Applications 018303 Application 018303
Type NDA
Sponsor US PHARMS HOLDINGS I Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;50MG Yes No 002 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 25MG;100MG Yes Yes 003 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE TABLET;ORAL 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N018303-001 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 N018303-002 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 N018303-003 LOPRESSOR HCT HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018303-001 AB
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 2 of 4 · 132 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018303-002 LOPRESSOR HCT 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018303-002 LOPRESSOR HCT 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018303-002 LOPRESSOR HCT 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018303-002 LOPRESSOR HCT 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018303-003 LOPRESSOR HCT 50MG;100MG TABLET / ORAL RLD 1984-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018303-003 LOPRESSOR HCT 50MG;100MG TABLET / ORAL RLD 1984-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL AB RLD, RS 1984-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1984-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1984-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1984-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1984-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1984-12-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N018303-003 LOPRESSOR HCT 50MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1984-12-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018303-001 LOPRESSOR HCT 25MG;50MG TABLET / ORAL AB RLD 1984-12-31 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N018303-002 LOPRESSOR HCT 25MG;100MG TABLET / ORAL RLD 1984-12-31 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 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 LOPRESSOR METOPROLOL TARTRATE VALIDUS PHARMACEUTICALS LLC b5f4fed2-369c-4808-a682-8a5b8cfdbb4f 2026-01-26 Warnings, Adverse reactions Exact identifier ndc (product): 30698-460
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 30698-460 Lopressor HCT metoprolol tartrate and hydrochlorothiazide Validus Pharmaceuticals LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 77157 SUPPL 2023-12-27 77131 SUPPL 2023-12-27 71010 SUPPL 2022-05-06 70976 SUPPL 2022-05-04 64387 SUPPL 2020-08-24 64337 SUPPL 2020-08-21 33473 SUPPL 2011-03-21 11201 SUPPL 2011-03-21 896 SUPPL 2010-01-06 33472 SUPPL 2009-09-17 895 SUPPL 2008-08-13 33471 SUPPL 2008-07-29 14976 SUPPL 2008-01-09 11200 SUPPL 2008-01-08 894 SUPPL 2006-09-18 14975 SUPPL 2003-11-25