Application Sponsors
| ANDA 090710 | SUN PHARM INDS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 5MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 10MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 20MG | 0 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2012-03-15 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-01-16 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2020-01-08 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-01-08 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 23 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUN PHARM INDS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90710
[companyName] => SUN PHARM INDS INC
[docInserts] => ["",""]
[products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)