Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201231
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201231Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/27/2024 | SUPPL-17 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/24/2023 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DEXMETHYLPHENIDATE HYDROCHLORIDE
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 208756 | RHODES PHARMS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 209211 | CEDIPROF INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208756 | RHODES PHARMS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 206931 | ABHAI INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 212631 | ALKEM LABS LTD |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 209211 | CEDIPROF INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 204534 | NOVEL LABS INC |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208756 | RHODES PHARMS |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 201231 | SUN PHARM INDUSTRIES |
| DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 207901 | TRIS PHARMA INC |
| FOCALIN | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 021278 | SANDOZ |