Details for New Drug Application (NDA): 022512
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The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 022512
Tradename: | PRADAXA |
Applicant: | Boehringer Ingelheim |
Ingredient: | dabigatran etexilate mesylate |
Patents: | 3 |
Pharmacology for NDA: 022512
Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 022512
Suppliers and Packaging for NDA: 022512
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0108 | 0597-0108-54 | 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE |
PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0108 | 0597-0108-60 | 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Oct 19, 2010 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Regulatory Exclusivity Expiration: | Jun 21, 2024 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y |
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