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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209112
Company: MCGUFF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASCOR ASCORBIC ACID 25,000MG/50ML (500MG/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
10/02/2017 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209112s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209112Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209112Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/08/2022 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209112s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209112Orig1s007ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/08/2022 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209112s007lbl.pdf
10/02/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209112s000lbl.pdf
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