Details for New Drug Application (NDA): 018878
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NDA 018878 describes INDOCIN, which is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla, and is included in five NDAs. It is available from one supplier. Additional details are available on the INDOCIN profile page.
The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. Additional details are available on the indomethacin sodium profile page.
The generic ingredient in INDOCIN 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 018878
| Tradename: | INDOCIN |
| Applicant: | Recordati Rare |
| Ingredient: | indomethacin sodium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 30, 1985 | TE: | RLD: | Yes | |||||
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