Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017871
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMSER METYROSINE 250MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/03/1979 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
07/15/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/30/2003 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17871slr011ltr.pdf
12/12/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/16/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/23/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/07/1988 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1985 SUPPL-6 Labeling

Label is not available on this site.

09/06/1985 SUPPL-5 Labeling

Label is not available on this site.

01/25/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/1980 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

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