Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088251
Company: PAI HOLDINGS PHARM
Company: PAI HOLDINGS PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXCHLORPHENIRAMINE MALEATE | DEXCHLORPHENIRAMINE MALEATE | 2MG/5ML | SYRUP;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 03/23/1984 | 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 |
|---|---|---|---|---|---|
| 04/20/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/12/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/04/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/18/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/10/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/24/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/22/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/08/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |