FDA Orange Book · active-ingredient family
Glipizide; metformin hydrochloride
Glipizide; metformin hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:METAGLIP · NDA 021460
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METAGLIPRLD×3 | BRISTOL MYERS SQUIBB | NDA 021460 | — | Oct 21, 2002 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | ZYDUS PHARMS USA INC | ANDA 078905 | AB | Jan 31, 2011 | |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | HERITAGE | ANDA 078728 | AB | Jun 23, 2010 | |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | SUN PHARM INDS INC | ANDA 077620 | — | Jan 11, 2008 | |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | NOVITIUM PHARMA | ANDA 078083 | — | Apr 12, 2007 | |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | TEVA PHARMS | ANDA 077270 | AB | Oct 28, 2005 | |
| GLIPIZIDE AND METFORMIN HYDROCHLORIDE×3 | EPIC PHARMA LLC | ANDA 077507 | AB | Oct 27, 2005 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Glipizide; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
