Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086863
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORPROMAZINE HYDROCHLORIDE | CHLORPROMAZINE HYDROCHLORIDE | 100MG/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 |
|---|---|---|---|---|---|---|---|
| 11/07/1980 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/2002 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/15/1999 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/25/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/09/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/13/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |