Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 008662
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYDRAZID ISONIAZID 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
09/29/1952 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
06/19/2002 SUPPL-18 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/05/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/25/2001 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/08/1997 SUPPL-15 Labeling Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

12/31/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/23/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/10/1986 SUPPL-11 Labeling

Label is not available on this site.

06/14/1988 SUPPL-10 Labeling

Label is not available on this site.

04/17/1979 SUPPL-9 Labeling

Label is not available on this site.

05/15/1978 SUPPL-8 Labeling

Label is not available on this site.

05/28/1976 SUPPL-6 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