Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071015
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 08/25/1987 | 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 |
|---|---|---|---|---|---|
| 08/30/2001 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 07/08/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/21/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/29/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/22/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 01/27/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |