Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088389
Company: DEPROCO
Company: DEPROCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIGNOSPAN FORTE | EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE | EQ 0.02MG BASE/ML;2% | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/30/2009 | 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 |
|---|---|---|---|---|---|
| 06/08/2021 | SUPPL-47 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/02/2018 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2017 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/29/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 10/04/2004 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 03/04/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/04/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/11/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/05/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/08/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |