Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040220
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/29/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/24/2014 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/24/2014 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/01/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/23/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 01/21/2003 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/20/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/02/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/19/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |