Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040300
Company: SPECGX LLC
Company: SPECGX LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/27/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40300ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/040300_methylphenidate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/28/2016 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2015 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/21/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2010 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/02/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/24/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/27/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf |
METHYLPHENIDATE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 206932 | ABHAI INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 213936 | ACCORD HLTHCARE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 211779 | ALKEM LABS LTD |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207416 | ASCENT PHARMS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 209753 | BIONPHARMA |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 208737 | CEDIPROF INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 091159 | MOUNTAIN |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 207884 | NOVEL LABS INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 202892 | OXFORD PHARMS |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 212697 | PRINSTON INC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 040300 | SPECGX LLC |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 090710 | SUN PHARM INDS INC |
| RITALIN | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 010187 | SANDOZ |