NDA 205053

MERCK SHARP DOHME

FDA Drug Application

Application #205053

Documents

• Review: 2015-03-16
• Letter: 2013-11-27
• Letter: 2014-06-12
• Letter: 2015-11-18
• Letter: 2015-11-18
• Label: 2013-11-26
• Label: 2015-08-19
• Label: 2015-11-19
• Label: 2015-11-19
• Summary Review: 2015-03-16
• Letter: 2016-09-15
• Label: 2017-01-24
• Letter: 2018-01-08
• Label: 2018-01-09
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2019-02-22
• Label: 2019-02-22
• Letter: 2019-03-12
• Label: 2019-03-12
• Letter: 2020-09-17
• Label: 2020-09-18
• Label: 2021-06-02
• Letter: 2021-06-03
• Letter: 2021-06-22
• Label: 2021-06-23
• Label: 2022-01-14
• Letter: 2022-01-18
• Label: 2022-01-21
• Letter: 2022-01-21

Application Sponsors

NDA 205053

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

100MG

1

NOXAFIL

POSACONAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-11-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2015-11-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-11-13	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-09-09	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	6	AP	2018-01-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-03-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2019-02-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-09-16	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2021-06-17	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2021-05-31	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-01-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2022-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	31
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	7
SUPPL	12	Null	6
SUPPL	13	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

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            [companyName] => MERCK SHARP DOHME
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            [actionDate] => 2019-03-11
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)