Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Glipizide Extended-release Tablets, 5 mg & 10 mg, (5mg strength approved; 10mg strength is ) Watson Lab. ANDA 76-467 9/8/03 Glipizide Extended-release Tablets, 10 mg, Andrx ANDA 76-159 8/22/03 Glipizide Tablets USP, 5 mg & 10 mg, Torpharm ANDA 75-795 Glucotrol XL (glipizide) Extended Release Tablets, Pfizer NDA 20-329/S15 9/17/03 9/29/03 Glucotrol XL (glipizide) Extended Release Tablets, Pfizer NDA 20-329/S-002 Metaglip (glipizide/metformin HCl) Tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg, Bristol-Myers Squibb, NDA 21-460 GLIPIZIDE Tablet, Extended Release; 10MG GLUCOTROL XL PFIZER 020329 GLIPIZIDE Tablet, Extended Release; 2.5MG GLUCOTROL XL PFIZER 020329 GLIPIZIDE Tablet, Extended Release; 5MG GLUCOTROL XL PFIZER 076467 GLIPIZIDE Tablet, Extended Release; 5MG GLIPIZIDE Watson 074438 GLIPIZIDE Tablet; 10MG GLIPIZIDE Alphapharm 074438 GLIPIZIDE Tablet; 5MG GLIPIZIDE Alphapharm 074550 GLIPIZIDE Tablet; 10MG GLIPIZIDE DURAMED Barr 074550 GLIPIZIDE Tablet; 5MG GLIPIZIDE DURAMED Barr 074378 GLIPIZIDE Tablet; 10MG GLIPIZIDE ENDO 074378 GLIPIZIDE Tablet; 5MG GLIPIZIDE ENDO 074305 GLIPIZIDE Tablet; 10MG GLIPIZIDE Geneva 074305 GLIPIZIDE Tablet; 5MG GLIPIZIDE Geneva 074542 GLIPIZIDE Tablet; 10MG GLIPIZIDE Geneva TECH 074542 GLIPIZIDE Tablet; 5MG GLIPIZIDE Geneva TECH 074497 GLIPIZIDE Tablet; 10MG GLIPIZIDE Ivax 074497 GLIPIZIDE Tablet; 5MG GLIPIZIDE Ivax 074226 GLIPIZIDE Tablet; 10MG GLIPIZIDE Mylan 074226 GLIPIZIDE Tablet; 5MG GLIPIZIDE Mylan 017783 GLIPIZIDE Tablet; 10MG GLUCOTROL PFIZER 017783 GLIPIZIDE Tablet; 5MG GLUCOTROL PFIZER 074619 GLIPIZIDE Tablet; 10MG GLIPIZIDE Pliva 074619 GLIPIZIDE Tablet; 5MG GLIPIZIDE Pliva 074387 GLIPIZIDE Tablet; 10MG GLIPIZIDE Teva 074387 GLIPIZIDE Tablet; 5MG GLIPIZIDE Teva 075795 GLIPIZIDE Tablet; 10MG GLIPIZIDE Torpharm 075795 GLIPIZIDE Tablet; 5MG GLIPIZIDE Torpharm 074370 GLIPIZIDE Tablet; 10MG GLIPIZIDE Watson LAB 074370 GLIPIZIDE Tablet; 5MG GLIPIZIDE Watson LAB 074223 GLIPIZIDE Tablet; 10MG GLIPIZIDE Watson 074223 GLIPIZIDE Tablet; 5MG GLIPIZIDE Watson 021460 GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 2.5MG;250MG METAGLIP BRISTOL MYERS SQUIBB 021460 GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 2.5MG;500MG METAGLIP BRISTOL MYERS SQUIBB 021460 GLIPIZIDE; METFORMIN HYDROCHLORIDE Tablet; 5MG;500MG METAGLIP BRISTOL MYERS SQUIBB Glipizide Extended-release Tablets, Watson Lab | Glipizide and Metformin Hydrochloride Tablets, CorePharma, Approval | Glipizide and Metformin Hydrochloride Tablets, Teva Pharma, Approval | Glipizide and Metformin Hydrochloride Tablets, Approval | Glipizide and Metformin Hydrochloride Tablets, Caraco Pharma, Approval | Metaglip (glipizide and metformin hydrochloride) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Glucotrol (glipizide) Tablets, Pfizer Inc., Packaging Addition | Glucotrol XL (glipizide) Extended-Release Tablets, Pfizer Inc., Packaging Addition ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com