Drugs@FDA: FDA-Approved Drugs
Company: SCHERING PLOUGH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DRIXORAL PLUS | ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 500MG;3MG;60MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
05/22/1987 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2003 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19453slr014ltr.pdf |
07/11/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/17/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/18/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/21/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/07/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/22/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/26/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/16/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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04/16/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/02/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/24/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |