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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

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