Details for New Drug Application (NDA): 214358
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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 214358
Tradename: | PRADAXA |
Applicant: | Boehringer Ingelheim |
Ingredient: | dabigatran etexilate mesylate |
Patents: | 1 |
Pharmacology for NDA: 214358
Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 214358
Suppliers and Packaging for NDA: 214358
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0425 | 0597-0425-78 | 1 BAG in 1 CARTON (0597-0425-78) / 60 PELLET in 1 BAG |
PRADAXA | dabigatran etexilate mesylate | PELLETS;ORAL | 214358 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0430 | 0597-0430-18 | 1 BAG in 1 CARTON (0597-0430-18) / 60 PELLET in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | PELLETS;ORAL | Strength | EQ 20MG BASE/PACKET | ||||
Approval Date: | Jun 21, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 21, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y |
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