Home Applications 050742 Application 050742
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 STROMECTOL IVERMECTIN TABLET;ORAL 6MG No No 002 STROMECTOL IVERMECTIN TABLET;ORAL 3MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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date N050742-001 STROMECTOL IVERMECTIN 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 N050742-002 STROMECTOL IVERMECTIN 3MG TABLET / ORAL AB RLD, RS 1998-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050742-002 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 1 of 3 · 84 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 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050742-001 STROMECTOL 6MG TABLET / ORAL RLD 1996-11-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050742-001 STROMECTOL 6MG TABLET / ORAL RLD 1996-11-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050742-001 STROMECTOL 6MG TABLET / ORAL 1996-11-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050742-001 STROMECTOL 6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1996-11-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050742-002 STROMECTOL 3MG TABLET / ORAL AB RLD, RS 1998-10-08 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme Corp. NDA Current 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme Corp. NDA Current 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme Corp. NDA Current 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme LLC NDA Current 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme Corp. NDA Current 0006-0032 STROMECTOL ivermectin Merck Sharp & Dohme Corp. NDA Current 55695-019 STROMECTOL ivermectin Department of State Health Services, Pharmacy Branch NDA Current