Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016000
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULLA SULFAMETER 500MG 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
07/01/1966 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
01/16/1981 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/30/1980 SUPPL-14 Labeling

Label is not available on this site.

06/27/1980 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1980 SUPPL-12 Labeling

Label is not available on this site.

01/10/1979 SUPPL-10 Labeling

Label is not available on this site.

02/13/1979 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1978 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/11/1977 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1975 SUPPL-1

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