ANDA 203335

MAYNE PHARMA INC

FDA Drug Application

Application #203335

Documents

• Letter: 2015-11-04

Application Sponsors

ANDA 203335

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG;30MG

0

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-30
REMS; REMS	SUPPL	5	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203335
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203335Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-5","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)