Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050299
Company: GLENMARK GENERICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NILSTAT NYSTATIN 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None Yes No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
04/14/1971 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/28/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/28/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/01/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1977 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/23/1974 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/22/1974 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/15/1974 SUPPL-9 Labeling

Label is not available on this site.

02/11/1974 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1974 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1972 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/28/1972 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/25/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1983 SUPPL-1 Manufacturing (CMC)-Formulation

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