Home Applications 017558 Application 017558
Type NDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROBINUL GLYCOPYRROLATE INJECTABLE;INJECTION 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017558-001 ROBINUL GLYCOPYRROLATE 0.2MG/ML INJECTABLE / INJECTION AP RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017558-001 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 2 of 2 · 44 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UTC 2022-10 N017558-001 ROBINUL 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N017558-001 ROBINUL 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N017558-001 ROBINUL 0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N017558-001 ROBINUL 0.2MG/ML INJECTABLE / INJECTION AP RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0641-6033 Glycopyrrolate Glycopyrrolate West-ward Pharmaceutical Corp. NDA Current 0641-6034 Glycopyrrolate Glycopyrrolate West-ward Pharmaceutical Corp. NDA Current 0641-6035 Glycopyrrolate Glycopyrrolate West-ward Pharmaceutical Corp. NDA Current 0641-6036 Glycopyrrolate Glycopyrrolate West-ward Pharmaceutical Corp. NDA Current 0641-6104 Robinul Robinul West-Ward Pharmaceuticals Corp. NDA Current 0641-6105 Robinul Robinul West-Ward Pharmaceuticals Corp. NDA Current 0641-6106 Robinul Robinul West-Ward Pharmaceuticals Corp. NDA Current 0641-6107 Robinul Robinul West-Ward Pharmaceuticals Corp. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85259 SUPPL 2026-03-04 85158 SUPPL 2026-02-25 85085 SUPPL 2026-02-20 85084 SUPPL 2026-02-20 82899 SUPPL 2025-07-21 82884 SUPPL 2025-07-17 79126 SUPPL 2024-07-18 79101 SUPPL 2024-07-16 79096 SUPPL 2024-07-15 54911 SUPPL 2018-07-18 54861 SUPPL 2018-07-09 20078 ORIG 2007-02-20 33305 SUPPL 2005-05-27 642 SUPPL 2005-05-27 13852 SUPPL 2004-11-08 13850 SUPPL 2004-11-08 641 SUPPL 2004-11-08 639 SUPPL 2004-11-08 13851 SUPPL 2003-07-06 640 SUPPL 2003-07-06