Details for New Drug Application (NDA): 090403
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The generic ingredient in INDOMETHACIN is indomethacin sodium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 090403
Tradename: | INDOMETHACIN |
Applicant: | Zydus Lifesciences |
Ingredient: | indomethacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090403
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 090403
Suppliers and Packaging for NDA: 090403
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 090403 | ANDA | Proficient Rx LP | 63187-852 | 63187-852-08 | 8 CAPSULE in 1 BOTTLE (63187-852-08) |
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 090403 | ANDA | Proficient Rx LP | 63187-852 | 63187-852-15 | 15 CAPSULE in 1 BOTTLE (63187-852-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Nov 15, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Nov 15, 2010 | TE: | AB | RLD: | No |
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