Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088877
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/11/1985 | 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 |
|---|---|---|---|---|---|
| 05/28/2002 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/26/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/02/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/26/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/02/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/27/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/28/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/27/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/29/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/29/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |