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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016832
Company: ABBOTT

Other Important Information from FDA

Products on NDA 016832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYLERT	PEMOLINE	18.75MG	TABLET;ORAL	Discontinued	None	No	No
CYLERT	PEMOLINE	37.5MG	TABLET;ORAL	Discontinued	None	No	No
CYLERT	PEMOLINE	75MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016832

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/1975	ORIG-1	Approval	Type 1 - New Molecular Entity	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-22	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-21	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/2002	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
09/04/2002	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
05/28/1999	SUPPL-18	Labeling		Label is not available on this site.
05/08/1998	SUPPL-16	Manufacturing (CMC)-Packaging	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016832a_s016.pdf
12/12/1997	SUPPL-15	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016832a_s015.pdf
09/09/1996	SUPPL-14	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s014.pdf
04/11/1996	SUPPL-13	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s013.pdf
02/16/1990	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-11	Labeling		Label is not available on this site.
09/06/1984	SUPPL-9	Labeling		Label is not available on this site.
03/30/1979	SUPPL-6	Labeling		Label is not available on this site.
06/06/1978	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/12/1977	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/14/1979	SUPPL-3	Labeling		Label is not available on this site.
03/25/1975	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 016832

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2003	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf

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