Details for New Drug Application (NDA): 215233
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NDA 215233 describes DABIGATRAN ETEXILATE MESYLATE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and MSN, and is included in five NDAs. It is available from eight 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 215233
| Tradename: | DABIGATRAN ETEXILATE MESYLATE |
| Applicant: | Alembic |
| Ingredient: | dabigatran etexilate mesylate |
| Patents: | 0 |
Pharmacology for NDA: 215233
| Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 215233
Suppliers and Packaging for NDA: 215233
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 215233 | ANDA | Alembic Pharmaceuticals Limited | 46708-634 | 46708-634-06 | 10 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK |
| DABIGATRAN ETEXILATE MESYLATE | dabigatran etexilate mesylate | CAPSULE;ORAL | 215233 | ANDA | Alembic Pharmaceuticals Limited | 46708-634 | 46708-634-60 | 60 CAPSULE in 1 BOTTLE (46708-634-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jun 14, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
| Approval Date: | Aug 12, 2024 | TE: | AB | RLD: | No | ||||
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