Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 013483
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MALEATE; PSEUDOEPHEDRINE SULFATE 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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.

07/11/2001 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2000 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1998 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/18/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/08/1986 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1984 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1986 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1985 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1982 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1982 SUPPL-17 Unspecified

Label is not available on this site.

09/13/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/1981 SUPPL-15 Labeling

Label is not available on this site.

07/21/1980 SUPPL-14 Labeling

Label is not available on this site.

06/13/1980 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1978 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/15/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1976 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

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