An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017703
Company: ABBOTT

Other Important Information from FDA

Products on NDA 017703

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017703

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.

Labels for NDA 017703

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

Top