Home Applications 050587 Application 050587
Type NDA
Sponsor MERCK Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRIMAXIN CILASTATIN SODIUM; IMIPENEM POWDER;INTRAVENOUS EQ 250MG BASE/VIAL;250MG/VIAL Yes No 002 PRIMAXIN CILASTATIN SODIUM; IMIPENEM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL;500MG/VIAL Yes Yes
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 N050587-001 PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 N050587-002 PRIMAXIN CILASTATIN SODIUM; IMIPENEM EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050587-002 AP
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 N050587-001 PRIMAXIN EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N050587-002 PRIMAXIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050587-001 PRIMAXIN EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 e64feba35796…2022-09-29 23:25 UTC 2022-09 N050587-002 PRIMAXIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050587-001 PRIMAXIN EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050587-002 PRIMAXIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050587-001 PRIMAXIN EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER / INTRAVENOUS RLD 1985-11-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050587-002 PRIMAXIN EQ 500MG BASE/VIAL;500MG/VIAL POWDER / INTRAVENOUS AP RLD, RS 1985-11-26 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme Corp. NDA Current 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme Corp. NDA Current 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme Corp. NDA Current 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme Corp. NDA Current 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme LLC NDA Current 0006-3516 PRIMAXIN imipenem and cilastatin sodium Merck Sharp & Dohme Corp. NDA Current