NDA 211158

AMNEAL PHARMS LLC

FDA Drug Application

Application #211158

Documents

• Label: 2018-08-03
• Letter: 2018-08-03
• Review: 2018-11-07
• Letter: 2020-08-03
• Label: 2020-08-03
• Letter: 2020-11-12
• Label: 2020-11-13
• Label: 2021-05-13

Application Sponsors

NDA 211158

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

50MG/VIAL

0

TIGECYCLINE

TIGECYCLINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-08-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-05-12	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211158
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211158s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/211158s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/02\/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\\\/211158s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/211158Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/211158Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/211158s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/211158Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-07-31
        )

)