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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018506
Company: SCHERING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRINALIN AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE 1MG;120MG 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
03/23/1982 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
12/12/2002 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr025ltr.pdf
11/01/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18506slr024ltr.pdf
11/01/2000 SUPPL-22 Manufacturing (CMC)-Control Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml
08/04/2000 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
04/25/2000 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
09/13/2000 SUPPL-18 Manufacturing (CMC)-Control Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml
05/18/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
07/01/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
04/20/1992 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
01/24/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
01/24/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/06/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
05/01/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/08/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
09/18/1984 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/04/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
08/31/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
02/24/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
02/06/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.
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