Details for New Drug Application (NDA): 018829
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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 018829
Tradename: | INDOMETHACIN |
Applicant: | Chartwell Molecules |
Ingredient: | indomethacin |
Patents: | 0 |
Pharmacology for NDA: 018829
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 018829
Suppliers and Packaging for NDA: 018829
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 018829 | NDA | Chartwell RX, LLC | 62135-067 | 62135-067-18 | 180 CAPSULE in 1 BOTTLE (62135-067-18) |
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 018829 | NDA | Chartwell RX, LLC | 62135-067 | 62135-067-90 | 90 CAPSULE in 1 BOTTLE (62135-067-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 6, 1984 | TE: | AB | RLD: | No |
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