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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205703
Company: HQ SPCLT PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE 2GM/100ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER ESMOLOL HYDROCHLORIDE 2.5GM/250ML (10MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/07/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205703s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205703Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205703Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/205703Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2024 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205703s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205703Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/02/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205703s003lbl.pdf
04/07/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205703s000lbl.pdf
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