Application Sponsors
| ANDA 201952 | MICRO LABS LTD INDIA | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 325MG;37.5MG | 0 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2012-12-14 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2017-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-08-03 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-08-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 19 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
TE Codes
CDER Filings
MICRO LABS LTD INDIA
cder:Array
(
[0] => Array
(
[ApplNo] => 201952
[companyName] => MICRO LABS LTD INDIA
[docInserts] => ["",""]
[products] => [{"drugName":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/14\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-9","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/23\/2017","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/01\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-09-18
)
)