Drugs@FDA: FDA-Approved Drugs
Company: SCHERING PLOUGH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DISOPHROL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DRIXORAL | DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE | 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/18/1963 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 03/10/2005 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/13483s042ltr.pdf |
| 06/29/2001 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/2001 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/06/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/17/2000 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/2001 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/18/2000 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/06/1998 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/22/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/18/1998 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/24/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/08/1986 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/22/1986 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/21/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/20/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/01/1982 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/13/1982 | SUPPL-17 | Unspecified |
Label is not available on this site. |
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| 09/13/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/11/1981 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 07/21/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/13/1980 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/07/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/02/1978 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/15/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/14/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/30/1976 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |