Details for New Drug Application (NDA): 074550
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The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.
Summary for 074550
Tradename: | GLIPIZIDE |
Applicant: | Accord Hlthcare |
Ingredient: | glipizide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 074550
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLIPIZIDE | glipizide | TABLET;ORAL | 074550 | ANDA | Accord Healthcare Inc. | 16729-139 | 16729-139-00 | 100 TABLET in 1 BOTTLE (16729-139-00) |
GLIPIZIDE | glipizide | TABLET;ORAL | 074550 | ANDA | Accord Healthcare Inc. | 16729-139 | 16729-139-16 | 500 TABLET in 1 BOTTLE (16729-139-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 11, 1997 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Sep 11, 1997 | TE: | AB | RLD: | No |
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