Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLIN ER | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METHYLIN ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/09/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75629ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-629_Mythylphenidate%20Hydrochloride.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/25/2021 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
06/14/2021 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
06/14/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2016 | SUPPL-15 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/28/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
03/20/2015 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/21/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
12/19/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/10/2010 | SUPPL-7 | Labeling |
Label is not available on this site. |
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04/24/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
METHYLIN ER
TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLIN ER | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075629 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207488 | ABHAI LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210992 | GRANULES |
TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLIN ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075629 | SPECGX LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207488 | ABHAI LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212288 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210992 | GRANULES |