Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 007638
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLOR-TRIMETON CHLORPHENIRAMINE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
CHLOR-TRIMETON CHLORPHENIRAMINE MALEATE 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No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
08/15/1950 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
12/23/2015 SUPPL-38 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/007638Orig1s038ltr.pdf
02/04/2008 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/007638s033ltr.pdf
01/19/2006 SUPPL-32 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/007638s032ltr.pdf
03/06/2002 SUPPL-29 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/26/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1998 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1997 SUPPL-24 Labeling

Label is not available on this site.

07/08/1986 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1986 SUPPL-22 Efficacy-Rx To OTC Switch

Label is not available on this site.

09/18/1984 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1986 SUPPL-18 Labeling

Label is not available on this site.

02/18/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1983 SUPPL-16 Labeling

Label is not available on this site.

08/30/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1982 SUPPL-13 Efficacy-Rx To OTC Switch

Label is not available on this site.

10/30/1981 SUPPL-12 Labeling

Label is not available on this site.

06/11/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/30/1980 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1980 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/20/1979 SUPPL-7 Labeling

Label is not available on this site.

01/05/1979 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1978 SUPPL-2 Labeling

Label is not available on this site.

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