Details for New Drug Application (NDA): 208040
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NDA 208040 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 sixteen suppliers. Additional details are available on the DABIGATRAN ETEXILATE MESYLATE profile page.
The generic ingredient in DABIGATRAN ETEXILATE MESYLATE is dabigatran etexilate mesylate. There is one drug master file entry 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 is one drug master file entry for this compound. Eighteen 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 |
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 | Major Pharmaceuticals | 0904-7253 | 0904-7253-04 | 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) |
| DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 208040 | ANDA | Major Pharmaceuticals | 0904-7253 | 0904-7253-68 | 6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) |
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 | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
| Approval Date: | Sep 11, 2024 | TE: | AB | RLD: | No | ||||
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