Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE |
| 002 | TABLET, CHEWABLE;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE |
| 003 | TABLET, CHEWABLE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | METHYLIN | METHYLPHENIDATE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2006-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2007-06-07 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2010-10-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 6 | AP | 2013-06-14 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-12-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-09-15 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2015-04-17 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 10 | AP | 2017-01-04 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-06-25 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 6 |
| SUPPL | 11 | Null | 6 |
CDER Filings
SPECGX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 21475
[companyName] => SPECGX LLC
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021475s010lbl.pdf#page=13"]
[products] => [{"drugName":"METHYLIN","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"METHYLIN","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"METHYLIN","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021475s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021475s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021419s009,021475s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021475s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021475s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2010","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021475s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021419s001,021475s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021475s002,021419s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21475_methylin_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"METHYLIN","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"METHYLIN","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"METHYLIN","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-01-04
)
)