ANDA 207407

LANNETT CO INC

FDA Drug Application

Application #207407

Documents

• Letter: 2016-12-29
• Label: 2017-01-31

Application Sponsors

ANDA 207407

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

80MG/ML;20MG/ML

0

LOPINAVIR AND RITONAVIR

LOPINAVIR; RITONAVIR

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-12-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-04-27	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-04-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-04-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-04-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

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(
    [0] => Array
        (
            [ApplNo] => 207407
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPINAVIR AND RITONAVIR","activeIngredients":"LOPINAVIR; RITONAVIR","strength":"80MG\/ML;20MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207407Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207407Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207407Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/27\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/27\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-27
        )

)