Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210066
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
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 |
---|---|---|---|---|---|---|---|
11/21/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210066Orig1s000TAltr.pdf |
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 |