Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017703
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYLERT PEMOLINE 37.5MG TABLET, CHEWABLE;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
01/30/1976 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2003 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr018ltr.pdf
01/06/2003 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1999 SUPPL-16 Labeling

Label is not available on this site.

05/13/1998 SUPPL-14 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/017703a_s014.pdf
12/12/1997 SUPPL-13 Labeling

Label is not available on this site.

09/09/1996 SUPPL-12 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-017703a_s012.pdf
04/11/1996 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-017703a_s011.pdf
02/16/1990 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/15/1987 SUPPL-9 Labeling

Label is not available on this site.

09/06/1984 SUPPL-7 Labeling

Label is not available on this site.

03/30/1979 SUPPL-4 Labeling

Label is not available on this site.

03/14/1979 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf

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