Details for New Drug Application (NDA): 203501
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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 203501
Tradename: | INDOMETHACIN |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | indomethacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203501
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203501
Suppliers and Packaging for NDA: 203501
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 203501 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-325 | 68462-325-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-01) |
INDOMETHACIN | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 203501 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-325 | 68462-325-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68462-325-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 75MG | ||||
Approval Date: | Jun 22, 2017 | TE: | AB | RLD: | No |
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