Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215233
Company: ALEMBIC
Company: ALEMBIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/14/2024 | ORIG-2 | Tentative Approval | STANDARD |
Label is not available on this site. |
|||
| 06/14/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DABIGATRAN ETEXILATE MESYLATE
CAPSULE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215233 | ALEMBIC |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208040 | ALKEM LABS LTD |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208070 | APOTEX |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207961 | HETERO LABS LTD III |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213879 | MSN |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 75MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022512 | BOEHRINGER INGELHEIM |
CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 215233 | ALEMBIC |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208040 | ALKEM LABS LTD |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 208070 | APOTEX |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207961 | HETERO LABS LTD III |
| DABIGATRAN ETEXILATE MESYLATE | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | No | AB | 213879 | MSN |
| PRADAXA | DABIGATRAN ETEXILATE MESYLATE | EQ 150MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 022512 | BOEHRINGER INGELHEIM |