Details for New Drug Application (NDA): 209525
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The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
Summary for 209525
Tradename: | ICOSAPENT ETHYL |
Applicant: | Teva Pharms Usa |
Ingredient: | icosapent ethyl |
Patents: | 0 |
Suppliers and Packaging for NDA: 209525
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209525 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0126 | 0480-0126-49 | 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0126-49) |
ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209525 | ANDA | Teva Pharmaceuticals, Inc. | 0480-0127 | 0480-0127-89 | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (0480-0127-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Sep 11, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1GM | ||||
Approval Date: | Sep 11, 2020 | TE: | AB | RLD: | No |
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