Drugs@FDA: FDA-Approved Drugs
Company: LANNETT CO INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
12/23/1977 | 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 |
---|---|---|---|---|---|
01/21/2016 | SUPPL-45 | Labeling-Medication Guide |
Label is not available on this site. |
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01/21/2016 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
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01/21/2016 | SUPPL-43 | Labeling |
Label is not available on this site. |
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01/21/2016 | SUPPL-42 | Labeling |
Label is not available on this site. |
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01/21/2016 | SUPPL-41 | Labeling |
Label is not available on this site. |
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01/21/2016 | SUPPL-39 | Labeling |
Label is not available on this site. |
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01/21/2016 | SUPPL-38 | Labeling |
Label is not available on this site. |
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01/21/2016 | SUPPL-37 | Labeling |
Label is not available on this site. |
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12/28/2005 | SUPPL-36 | Labeling |
Label is not available on this site. |
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07/19/2004 | SUPPL-35 | Labeling |
Label is not available on this site. |
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12/09/2002 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/09/2002 | SUPPL-31 | Labeling |
Label is not available on this site. |
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11/08/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
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11/24/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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11/24/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1998 | SUPPL-23 | Labeling |
Label is not available on this site. |
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07/02/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
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06/30/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1992 | SUPPL-19 | Bioequivalence |
Label is not available on this site. |
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05/10/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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12/10/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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12/10/1984 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |