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): 205053
Company: MERCK SHARP DOHME

Summary Review

Products on NDA 205053

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOXAFIL	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205053

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205053s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205053Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205053Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022003Orig1s028, 205053Orig1s014, 205596Orig1s015, 214770Orig1s002ltr.pdf
01/20/2022	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205053Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205053Orig1s013ltr.pdf
05/31/2021	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000,205053Orig1s012,205596Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214770Orig1s000;%20205053Orig1s012;%20205596Orig1s012ltr.pdf
06/17/2021	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205053s011,205596s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205053Orig1s011;%20205596Orig1s013ltr.pdf
09/16/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010ltr.pdf
02/21/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022003Orig1s025,205053Orig1s009,205596Orig1s008ltr.pdf
03/11/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s024,205053s008,205596s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022003Orig1s024, 205053Orig1s008, 205596Orig1s007ltr.pdf
01/04/2018	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022003Orig1s022,205053Orig1s006,205596Orig1s005ltr.pdf
09/09/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022003Orig1s021,205053Orig1s005,205596Orig1s004ltr.pdf
11/13/2015	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf
11/13/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022003Orig1s018,s020,205053Orig1s002,s004,205596Orig1s001,s003ltr.pdf
06/11/2014	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205053s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205053Orig1s001ltr.pdf

Labels for NDA 205053

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205053Orig1s013lbl.pdf
01/13/2022	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022003s028,205053s014,205596s015,214770s002lbl.pdf
06/17/2021	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205053s011,205596s013lbl.pdf
05/31/2021	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770Orig1s000,205053Orig1s012,205596Orig1s012lbl.pdf
09/16/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf
09/16/2020	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022003Orig1s026,205053Orig1s010,205596Orig1s010lbl.pdf
03/11/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s024,205053s008,205596s007lbl.pdf
02/21/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf
01/04/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022003s022,205053s006,205596s005lbl.pdf
09/09/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022003s021,205053s005,205596s004lbl.pdf
11/13/2015	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
11/13/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022003s018s020,0205053s002s004,0205596s001s003lbl.pdf
06/11/2014	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205053s1lbl.pdf
11/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205053s000lbl.pdf

Therapeutic Equivalents for NDA 205053

NOXAFIL

TABLET, DELAYED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOXAFIL	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	205053	MERCK SHARP DOHME
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	207355	ACTAVIS LABS FL INC
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213454	AET PHARMA
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216626	AMNEAL
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214476	BIOCON PHARMA
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212500	DR REDDYS
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	214321	HETERO LABS LTD III
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212411	SINOTHERAPEUTICS INC
POSACONAZOLE	POSACONAZOLE	100MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	212226	SPECGX LLC

Top