Details for New Drug Application (NDA): 017814
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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 017814
Tradename: | INDOCIN |
Applicant: | Zyla Life Sciences |
Ingredient: | indomethacin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017814
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUPPOSITORY;RECTAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 13, 1984 | TE: | RLD: | Yes |
Expired US Patents for NDA 017814
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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