Details for New Drug Application (NDA): 076174
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The generic ingredient in ETODOLAC is etodolac. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the etodolac profile page.
Pharmacology for NDA: 076174
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076174
Suppliers and Packaging for NDA: 076174
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 076174 | ANDA | NORTHSTAR RX LLC | 16714-497 | 16714-497-01 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01) |
ETODOLAC | etodolac | TABLET, EXTENDED RELEASE;ORAL | 076174 | ANDA | NORTHSTAR RX LLC | 16714-497 | 16714-497-02 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 400MG | ||||
Approval Date: | Mar 13, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Mar 13, 2003 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
Approval Date: | Mar 13, 2003 | TE: | AB | RLD: | No |
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