Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204115
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204115Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/28/2024 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/25/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |