Details for New Drug Application (NDA): 079175
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The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 079175
Tradename: | INDOMETHACIN |
Applicant: | Avanthi Inc |
Ingredient: | indomethacin |
Patents: | 0 |
Pharmacology for NDA: 079175
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079175
Suppliers and Packaging for NDA: 079175
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 079175 | ANDA | KVK-Tech, Inc. | 10702-016 | 10702-016-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-01) |
INDOMETHACIN | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 079175 | ANDA | KVK-Tech, Inc. | 10702-016 | 10702-016-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10702-016-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 75MG | ||||
Approval Date: | Mar 6, 2009 | TE: | AB | RLD: | No |
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