Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083051
Company: INTL MEDICATION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANNITOL 25% MANNITOL 12.5GM/50ML 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
08/29/1975 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/17/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/14/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/29/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-13 Labeling

Label is not available on this site.

12/17/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/07/1992 SUPPL-11 Labeling

Label is not available on this site.

01/29/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/29/1985 SUPPL-5 Manufacturing (CMC)

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