Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074305
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription AB No No
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription AB 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
04/07/1995 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
04/11/2017 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

04/11/2017 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

05/19/2009 SUPPL-23 Labeling

Label is not available on this site.

03/25/2002 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/2001 SUPPL-10 Labeling

Label is not available on this site.

09/21/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1999 SUPPL-5 Labeling

Label is not available on this site.

02/01/1999 SUPPL-3 Labeling

Label is not available on this site.

02/01/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/22/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

GLIPIZIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074550 ACCORD HLTHCARE
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074497 ANI PHARMS INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 5MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074550 ACCORD HLTHCARE
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074497 ANI PHARMS INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 10MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

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