Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019453
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.

03/06/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/26/1997 SUPPL-6 Labeling

Label is not available on this site.

04/16/1996 SUPPL-5 Labeling

Label is not available on this site.

04/16/1996 SUPPL-4 Labeling

Label is not available on this site.

03/02/1994 SUPPL-3 Labeling

Label is not available on this site.

02/24/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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