Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English