Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205327
Company: OSMOTICA PHARM US
Company: OSMOTICA PHARM US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/28/2017 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205327Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205327Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/11/2024 | SUPPL-20 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/11/2024 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
05/21/2018 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205327Orig1s000lbl.pdf |
METHYLPHENIDATE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 18MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | DR REDDYS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 27MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | DR REDDYS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 36MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076772 | ACTAVIS LABS FL |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | DR REDDYS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 54MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021121 | JANSSEN PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076655 | ACTAVIS LABS FL |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214447 | ALKEM LABS LTD |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211918 | ANDOR PHARMS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211009 | ASCENT PHARMS INC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206726 | AUROLIFE PHARMA LLC |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213473 | DR REDDYS |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205135 | SUN PHARM INDS INC |
TABLET, EXTENDED RELEASE;ORAL; 72MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076655 | ACTAVIS LABS FL |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205327 | OSMOTICA PHARM US |
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 72MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 217229 | SUN PHARM INDS INC |