Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209898
Company: INDOCO
Company: INDOCO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/17/2022 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/17/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
APIXABAN
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210180 | ACCORD HLTHCARE |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210091 | APOTEX |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 210066 | HETERO LABS LTD V |
| APIXABAN | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | No | AB | 209898 | INDOCO |
| ELIQUIS | APIXABAN | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 202155 | BRISTOL MYERS SQUIBB |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210180 | ACCORD HLTHCARE |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210091 | APOTEX |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 210066 | HETERO LABS LTD V |
| APIXABAN | APIXABAN | 5MG | TABLET;ORAL | Prescription | No | AB | 209898 | INDOCO |
| ELIQUIS | APIXABAN | 5MG | TABLET;ORAL | Prescription | Yes | AB | 202155 | BRISTOL MYERS SQUIBB |