Details for New Drug Application (NDA): 021695
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The generic ingredient in ANTARA (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021695
Tradename: | ANTARA (MICRONIZED) |
Applicant: | Lupin |
Ingredient: | fenofibrate |
Patents: | 2 |
Suppliers and Packaging for NDA: 021695
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695 | NDA | Lupin Pharmaceuticals, Inc. | 27437-109 | 27437-109-06 | 30 CAPSULE in 1 BOTTLE (27437-109-06) |
ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695 | NDA | Lupin Pharmaceuticals, Inc. | 27437-110 | 27437-110-06 | 30 CAPSULE in 1 BOTTLE (27437-110-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 43MG | ||||
Approval Date: | Nov 30, 2004 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 87MG | ||||
Approval Date: | Nov 30, 2004 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 130MG | ||||
Approval Date: | Nov 30, 2004 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021695
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-002 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-001 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695-003 | Nov 30, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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