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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201849
Company: FRESENIUS KABI USA

Products on NDA 201849

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL	POWDER;INTRAMUSCULAR, INTRAVENOUS	Prescription	None	Yes	Yes
GLUCAGON	GLUCAGON HYDROCHLORIDE	EQ 1MG BASE/VIAL	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201849

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/08/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201849Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2022	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201849s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201849Orig1s013ltr.pdf
07/29/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201849s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201849Orig1s009ltr.pdf
09/09/2019	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201849s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201849Orig1s005ltr.pdf
11/03/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/01/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s002ltr.pdf
11/03/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201849

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201849s013lbl.pdf
07/14/2022	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201849s013lbl.pdf
07/29/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201849s009lbl.pdf
09/09/2019	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201849s005lbl.pdf
12/01/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf

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