Details for New Drug Application (NDA): 077091
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The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 077091
Tradename: | GLIMEPIRIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | glimepiride |
Patents: | 0 |
Suppliers and Packaging for NDA: 077091
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077091 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-121 | 43063-121-30 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-121-30) |
GLIMEPIRIDE | glimepiride | TABLET;ORAL | 077091 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-121 | 43063-121-90 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-121-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 6, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Oct 6, 2005 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
Approval Date: | Oct 6, 2005 | TE: | AB | RLD: | No |
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