Details for New Drug Application (NDA): 207961
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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 207961
Tradename: | DABIGATRAN ETEXILATE MESYLATE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | dabigatran etexilate mesylate |
Patents: | 0 |
Pharmacology for NDA: 207961
Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 207961
Suppliers and Packaging for NDA: 207961
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 207961 | ANDA | Camber Pharmaceuticals, Inc. | 31722-621 | 31722-621-60 | 60 CAPSULE in 1 BOTTLE (31722-621-60) |
DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 207961 | ANDA | Camber Pharmaceuticals, Inc. | 31722-622 | 31722-622-60 | 60 CAPSULE in 1 BOTTLE (31722-622-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | May 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | May 6, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
Approval Date: | Aug 13, 2024 | TE: | AB | RLD: | No |
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