Application Sponsors
ANDA 215523 | ASCENT PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Prescription | 006 |
Prescription | 007 |
Prescription | 008 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
004 | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
005 | CAPSULE, EXTENDED RELEASE;ORAL | 25MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
006 | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
007 | CAPSULE, EXTENDED RELEASE;ORAL | 35MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
008 | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | 0 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-12-08 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
005 | Prescription | AB |
006 | Prescription | AB |
007 | Prescription | AB |
008 | Prescription | AB |
CDER Filings
ASCENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215523
[companyName] => ASCENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"35MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-12-08
)
)