Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009818
Company: MONARCH PHARMS

Products on NDA 009818

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KEMADRIN	PROCYCLIDINE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	No	No
KEMADRIN	PROCYCLIDINE HYDROCHLORIDE	2MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009818

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/1955	ORIG-1	Approval	Type 1 - New Molecular Entity	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
07/01/2011	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009818s018ltr.pdf
09/03/1982	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/19/1980	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
06/14/1979	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/10/1978	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/10/1978	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/09/1977	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/27/1976	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/25/1974	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 009818

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2011	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009818s018lbl.pdf