Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079031
Company: BARR LABS INC
Company: BARR LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 10/15/2014 | ORIG-2 | Approval |
Label is not available on this site. |
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| 07/13/2012 | 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 |
|---|---|---|---|---|---|
| 04/19/2023 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 04/19/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 04/19/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 04/19/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/19/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |