An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	AP	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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209112Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209112Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209112Orig1s009.pdf
04/23/2023	SUPPL-8	Manufacturing (CMC)-Facility	Review (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209112Orig1s008.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209112Orig1s008.pdf
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

Therapeutic Equivalents for NDA 209112

ASCOR

SOLUTION;INTRAVENOUS; 25,000MG/50ML (500MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ASCOR	ASCORBIC ACID	25,000MG/50ML (500MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	209112	MCGUFF
ASCORBIC ACID	ASCORBIC ACID	25,000MG/50ML (500MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217131	FRESENIUS KABI USA

Top