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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211962
Company: HIKMA

Products on NDA 211962

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211962

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/15/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211962Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211962Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-17	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211962s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211962Orig1s017ltr.pdf
06/26/2025	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211962s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211962Orig1s014ltr.pdf
01/29/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211962Orig1s011ltr.pdf
05/28/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211962Orig1s009ltr.pdf
09/03/2020	SUPPL-3	Labeling-Proprietary Name Change	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211962s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211962Orig1s003ltr.pdf

Labels for NDA 211962

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-17	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211962s017lbl.pdf
06/26/2025	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211962s014lbl.pdf
06/26/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211962s014lbl.pdf
05/28/2021	SUPPL-9	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s009lbl.pdf
01/29/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211962s011lbl.pdf
09/03/2020	SUPPL-3	Labeling-Proprietary Name Change	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211962s003lbl.pdf
02/15/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211962s000lbl.pdf

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