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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209112
Company: MCGUFF

Products on NDA 209112

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209112

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
01/17/2024	SUPPL-9		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209112Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209112Orig1s009ltr.pdf
04/23/2023	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
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

Labels for NDA 209112

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2024	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209112Orig1s009lbl.pdf
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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