Details for New Drug Application (NDA): 091240
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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 091240
Tradename: | INDOMETHACIN |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | indomethacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091240
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091240
Suppliers and Packaging for NDA: 091240
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 091240 | ANDA | Camber Pharmaceuticals, Inc. | 31722-542 | 31722-542-01 | 12 BOTTLE in 1 CASE (31722-542-01) / 100 CAPSULE in 1 BOTTLE |
INDOMETHACIN | indomethacin | CAPSULE;ORAL | 091240 | ANDA | Camber Pharmaceuticals, Inc. | 31722-542 | 31722-542-05 | 12 BOTTLE in 1 CASE (31722-542-05) / 500 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 25MG | ||||
Approval Date: | Apr 12, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
Approval Date: | Apr 12, 2011 | TE: | AB | RLD: | No |
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