Details for New Drug Application (NDA): 216184
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The generic ingredient in INDOMETHACIN 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 216184
Tradename: | INDOMETHACIN |
Applicant: | Zydus Lifesciences |
Ingredient: | indomethacin |
Patents: | 0 |
Pharmacology for NDA: 216184
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 216184
Suppliers and Packaging for NDA: 216184
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | SUPPOSITORY;RECTAL | 216184 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1852 | 70710-1852-7 | 5 BLISTER PACK in 1 CARTON (70710-1852-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1852-6) |
INDOMETHACIN | indomethacin | SUPPOSITORY;RECTAL | 216184 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1958 | 70710-1958-7 | 5 BLISTER PACK in 1 CARTON (70710-1958-7) / 6 SUPPOSITORY in 1 BLISTER PACK (70710-1958-6) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUPPOSITORY;RECTAL | Strength | 50MG | ||||
Approval Date: | Aug 2, 2023 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Jan 30, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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