Details for New Drug Application (NDA): 070651
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The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 070651
Tradename: | INDOMETHACIN |
Applicant: | Chartwell Molecules |
Ingredient: | indomethacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070651
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 070651
Suppliers and Packaging for NDA: 070651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070651 | ANDA | Chartwell RX, LLC | 62135-068 | 62135-068-18 | 180 CAPSULE in 1 BOTTLE (62135-068-18) |
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070651 | ANDA | Chartwell RX, LLC | 62135-068 | 62135-068-90 | 90 CAPSULE in 1 BOTTLE (62135-068-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Mar 5, 1986 | TE: | AB | RLD: | No |
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