Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072302
Company: TWI PHARMS
Company: TWI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | AB | No | No |
| ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;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 |
|---|---|---|---|---|---|---|---|
| 05/31/1990 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/08/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/12/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/19/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/22/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/07/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/03/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/30/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ATENOLOL AND CHLORTHALIDONE
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 |
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 |