Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214733
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VENETOCLAX | VENETOCLAX | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| VENETOCLAX | VENETOCLAX | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| VENETOCLAX | VENETOCLAX | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/15/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
VENETOCLAX
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENCLEXTA | VENETOCLAX | 10MG | TABLET;ORAL | Prescription | Yes | AB | 208573 | ABBVIE |
| VENETOCLAX | VENETOCLAX | 10MG | TABLET;ORAL | Prescription | No | AB | 214733 | DR REDDYS |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENCLEXTA | VENETOCLAX | 50MG | TABLET;ORAL | Prescription | Yes | AB | 208573 | ABBVIE |
| VENETOCLAX | VENETOCLAX | 50MG | TABLET;ORAL | Prescription | No | AB | 214733 | DR REDDYS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| VENCLEXTA | VENETOCLAX | 100MG | TABLET;ORAL | Prescription | Yes | AB | 208573 | ABBVIE |
| VENETOCLAX | VENETOCLAX | 100MG | TABLET;ORAL | Prescription | No | AB | 214733 | DR REDDYS |