Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | GRANULE;ORAL | EQ 200MG BASE/5ML | 0 | ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE |
002 | GRANULE;ORAL | EQ 400MG BASE/5ML | 0 | ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-10-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211991
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 200MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ERYTHROMYCIN ETHYLSUCCINATE","activeIngredients":"ERYTHROMYCIN ETHYLSUCCINATE","strength":"EQ 400MG BASE\/5ML","dosageForm":"GRANULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211991Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-10-23
)
)