Details for New Drug Application (NDA): 016059
✉ Email this page to a colleague
NDA 016059 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 016059
| Tradename: | INDOCIN |
| Applicant: | Zyla Life Sciences |
| Ingredient: | indomethacin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 016059
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
