Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017431
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUSERT PILO-20 PILOCARPINE 5MG INSERT, EXTENDED RELEASE;OPHTHALMIC 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
07/29/1974 ORIG-1 Approval Type 3 - New Dosage Form 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
01/20/1999 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1993 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1992 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

12/02/1991 SUPPL-26 Labeling

Label is not available on this site.

10/18/1990 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1990 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1990 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/09/1989 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/21/1987 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/08/1987 SUPPL-14 Labeling

Label is not available on this site.

11/19/1980 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/17/1981 SUPPL-11 Labeling

Label is not available on this site.

03/29/1979 SUPPL-10 Labeling

Label is not available on this site.

03/14/1979 SUPPL-9 Labeling

Label is not available on this site.

11/30/1978 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1978 SUPPL-7 Labeling

Label is not available on this site.

08/11/1977 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/01/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/1975 SUPPL-2 Manufacturing (CMC)-Control

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