Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016647
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINAGLUTE QUINIDINE GLUCONATE 324MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes 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
12/08/1969 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
04/26/2001 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/14/2000 SUPPL-38 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/31/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

06/24/2000 SUPPL-36 Labeling

Label is not available on this site.

07/01/1998 SUPPL-35 Labeling

Label is not available on this site.

11/16/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/17/1995 SUPPL-33 Labeling

Label is not available on this site.

06/30/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1987 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1989 SUPPL-29 Labeling

Label is not available on this site.

07/14/1986 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1985 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1984 SUPPL-24 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/23/1984 SUPPL-23 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/23/1984 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/07/1982 SUPPL-21 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/07/1981 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/07/1981 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1981 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1980 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1979 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1979 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1978 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1977 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/06/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/06/1977 SUPPL-5 Labeling

Label is not available on this site.

10/06/1977 SUPPL-4 Unspecified

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