Details for New Drug Application (NDA): 208040
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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. Nine suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 208040
Tradename: | DABIGATRAN ETEXILATE MESYLATE |
Applicant: | Alkem Labs Ltd |
Ingredient: | dabigatran etexilate mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208040
Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 208040
Suppliers and Packaging for NDA: 208040
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208040 | ANDA | Ascend Laboratories, LLC | 67877-474 | 67877-474-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-474-60) |
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208040 | ANDA | Ascend Laboratories, LLC | 67877-475 | 67877-475-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-475-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Mar 11, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | Mar 11, 2020 | TE: | AB | RLD: | No |
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