Application Sponsors
ANDA 074478 | YAOPHARMA CO LTD | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | EQ 5MG BASE | 0 | METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 10MG BASE | 0 | METOCLOPRAMIDE HYDROCHLORIDE | METOCLOPRAMIDE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1995-10-05 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-11-21 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2002-05-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-05-20 | |
LABELING; Labeling | SUPPL | 5 | AP | 2002-11-25 | |
LABELING; Labeling | SUPPL | 6 | AP | 2003-02-25 | |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
CDER Filings
YAOPHARMA CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 74478
[companyName] => YAOPHARMA CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)