Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019453
Company: SCHERING PLOUGH

Products on NDA 019453

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019453

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.