NDA 209481

MYLAN LABS LTD

FDA Drug Application

Application #209481

Documents

• Label: 2018-07-11
• Letter: 2018-07-16
• Review: 2019-01-07
• Label: 2019-08-12
• Letter: 2019-08-13
• Label: 2021-02-01
• Letter: 2021-02-01
• Letter: 2022-04-05
• Label: 2022-04-05

Application Sponsors

NDA 209481

MYLAN LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	POWDER;INTRAVENOUS	EQ 250MG BASE/VIAL	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	POWDER;INTRAVENOUS	EQ 750MG BASE/VIAL	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
003	POWDER;INTRAVENOUS	EQ 1.25GM BASE/VIAL	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
004	POWDER;INTRAVENOUS	EQ 1.5GM BASE/VIAL	1	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-07-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-09	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-01-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2022-04-04	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	5	Null	7
SUPPL	12	Null	15
SUPPL	16	Null	7

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209481
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 250MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 750MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1.25GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209481s005lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209481s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209481s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209481Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209481Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209481s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209481Orig1s005ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-08-09
        )

)