Details for New Drug Application (NDA): 208039
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NDA 208039 describes DABIGATRAN ETEXILATE MESYLATE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys, Hetero Labs Ltd Iii, MSN, and Mylan, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the DABIGATRAN ETEXILATE MESYLATE profile page.
The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 208039
| Tradename: | DABIGATRAN ETEXILATE MESYLATE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | dabigatran etexilate mesylate |
| Patents: | 0 |
Pharmacology for NDA: 208039
| Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 208039
Suppliers and Packaging for NDA: 208039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208039 | ANDA | Aurobindo Pharma Limited | 59651-973 | 59651-973-60 | 60 CAPSULE in 1 BOTTLE (59651-973-60) |
| DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208039 | ANDA | Aurobindo Pharma Limited | 59651-973 | 59651-973-61 | 10 BLISTER PACK in 1 CARTON (59651-973-61) / 6 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | May 14, 2025 | TE: | AB | RLD: | No | ||||
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