Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017938
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOBAN MOLINDONE HYDROCHLORIDE 20MG/ML CONCENTRATE;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
12/28/1979 ORIG-1 Approval Type 3 - New Dosage Form 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
01/15/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/2001 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17111s55ltr.pdf
08/21/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/25/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1984 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/19/1982 SUPPL-7 Labeling

Label is not available on this site.

11/16/1981 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1981 SUPPL-3 Labeling

Label is not available on this site.

01/05/1981 SUPPL-2 Labeling

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