Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080406
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;1% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;2% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/13/1972 | 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 |
|---|---|---|---|---|---|
| 11/16/1988 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 11/23/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/27/1996 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1996 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/18/1994 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1991 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/13/1990 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 05/24/1990 | SUPPL-37 | Labeling |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/06/1989 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1988 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 09/27/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 11/03/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/23/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |