Details for New Drug Application (NDA): 018332
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NDA 018332 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 018332
| Tradename: | INDOCIN |
| Applicant: | Zyla |
| Ingredient: | indomethacin |
| Patents: | 0 |
Pharmacology for NDA: 018332
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 018332
Suppliers and Packaging for NDA: 018332
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDOCIN | indomethacin | SUSPENSION;ORAL | 018332 | NDA | Zyla Life Sciences US LLC | 69344-101 | 69344-101-01 | 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 25MG/5ML | ||||
| Approval Date: | Oct 10, 1985 | TE: | AB | RLD: | Yes | ||||
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