Details for New Drug Application (NDA): 206561
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The generic ingredient in INDOMETHACIN SODIUM 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 206561
Tradename: | INDOMETHACIN SODIUM |
Applicant: | Navinta Llc |
Ingredient: | indomethacin sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206561
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 206561
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN SODIUM | indomethacin sodium | INJECTABLE;INJECTION | 206561 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-470 | 68382-470-01 | 1 VIAL in 1 CARTON (68382-470-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/VIAL | ||||
Approval Date: | Jul 19, 2017 | TE: | AP | RLD: | No |
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