Details for New Drug Application (NDA): 214358
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NDA 214358 describes PRADAXA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRADAXA profile page.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eight 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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Mar 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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