Documents
Application Sponsors
Marketing Status
Application Products
001 | SOLUTION;ORAL | EQ 5MG BASE/5ML | 0 | METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2001-01-26 | |
REMS; REMS | SUPPL | 2 | AP | 2010-07-30 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-02-28 | |
LABELING; Labeling | SUPPL | 4 | AP | 2012-08-31 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 75051
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"01\/26\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2001\\\/75-051_Metoclopramide_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2001-01-26
)
)