Details for New Drug Application (NDA): 091220
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The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the glimepiride profile page.
Summary for 091220
Tradename: | GLIMEPIRIDE |
Applicant: | Micro Labs |
Ingredient: | glimepiride |
Patents: | 0 |
Suppliers and Packaging for NDA: 091220
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GLIMEPIRIDE | glimepiride | TABLET;ORAL | 091220 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8332 | 0615-8332-39 | 30 TABLET in 1 BLISTER PACK (0615-8332-39) |
GLIMEPIRIDE | glimepiride | TABLET;ORAL | 091220 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8333 | 0615-8333-39 | 30 TABLET in 1 BLISTER PACK (0615-8333-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jun 29, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jun 29, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
Approval Date: | Jun 29, 2012 | TE: | RLD: | No |
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