Details for New Drug Application (NDA): 073314
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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 073314
Tradename: | INDOMETHACIN |
Applicant: | Cosette |
Ingredient: | indomethacin |
Patents: | 0 |
Pharmacology for NDA: 073314
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 073314
Suppliers and Packaging for NDA: 073314
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | SUPPOSITORY;RECTAL | 073314 | ANDA | Zyla Life Sciences US LLC | 69344-102 | 69344-102-33 | 30 SUPPOSITORY in 1 BOX (69344-102-33) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 50MG | ||||
Approval Date: | Aug 31, 1992 | TE: | AB | RLD: | No |
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