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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017558
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROBINUL GLYCOPYRROLATE 0.2MG/ML INJECTABLE;INJECTION Prescription AP Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/24/2026 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558s066lbl.pdf
09/25/2025 SUPPL-69 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017558Orig1s069lbl.pdf
07/16/2025 SUPPL-68 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/017558s068lbl.pdf
07/12/2024 SUPPL-63 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017558s063lbl.pdf
07/05/2018 SUPPL-62 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017558s062lbl.pdf
05/26/2005 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017558s053lbl.pdf
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