Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210028
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | AB | No | No |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | 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 |
---|---|---|---|---|---|---|---|
03/08/2019 | 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 |
---|---|---|---|---|---|
03/01/2024 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
ATENOLOL AND CHLORTHALIDONE
TABLET;ORAL; 50MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | No | AB | 215560 | NOVITIUM PHARMA |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | No | AB | 072302 | TWI PHARMS |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | No | AB | 213302 | UNICHEM |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | No | AB | 073665 | WATSON LABS |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | No | AB | 210028 | ZYDUS PHARMS |
TENORETIC 50 | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 018760 | TWI PHARMS |
TABLET;ORAL; 100MG;25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | No | AB | 215560 | NOVITIUM PHARMA |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | No | AB | 072302 | TWI PHARMS |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | No | AB | 213302 | UNICHEM |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | No | AB | 073665 | WATSON LABS |
ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | No | AB | 210028 | ZYDUS PHARMS |
TENORETIC 100 | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 018760 | TWI PHARMS |