Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087759
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROCHLORPERAZINE | PROCHLORPERAZINE EDISYLATE | EQ 5MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/01/1982 | 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 |
|---|---|---|---|---|---|
| 01/16/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/04/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/31/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 11/03/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/01/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/09/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |