Details for New Drug Application (NDA): 208070
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The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 208070
Tradename: | DABIGATRAN ETEXILATE MESYLATE |
Applicant: | Apotex |
Ingredient: | dabigatran etexilate mesylate |
Patents: | 0 |
Pharmacology for NDA: 208070
Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 208070
Suppliers and Packaging for NDA: 208070
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208070 | ANDA | Apotex Corp. | 60505-4347 | 60505-4347-2 | 10 BLISTER PACK in 1 CARTON (60505-4347-2) / 6 CAPSULE in 1 BLISTER PACK |
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208070 | ANDA | Apotex Corp. | 60505-4347 | 60505-4347-6 | 60 CAPSULE in 1 BOTTLE (60505-4347-6) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Dec 15, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
Approval Date: | Dec 15, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Dec 15, 2023 | TE: | AB | RLD: | No |
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