Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018397
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOR-TRIMETON CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE 8MG;120MG 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
03/31/1981 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/09/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/17/1998 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1997 SUPPL-9 Labeling

Label is not available on this site.

01/24/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/08/1986 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.

10/03/1984 SUPPL-4 Labeling

Label is not available on this site.

08/30/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1981 SUPPL-2 Labeling

Label is not available on this site.

05/04/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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