Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018760
Company: TWI PHARMS
Company: TWI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TENORETIC 100 | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| TENORETIC 50 | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1984 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018760s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018760Orig1s044ltr.pdf | |
| 10/31/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018760Orig1s029ltr.pdf | |
| 08/21/2011 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018760s028ltr.pdf | |
| 10/29/2008 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018760s027ltr.pdf | |
| 02/09/2005 | SUPPL-26 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18760s026ltr.pdf |
| 10/30/2003 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr025ltr.pdf |
| 01/31/2003 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr024ltr.pdf |
| 07/21/1999 | SUPPL-23 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf |
| 04/04/2000 | SUPPL-22 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf |
| 10/11/1996 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/04/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/04/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/05/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/05/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/18/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/26/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/08/1987 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 08/19/1985 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/17/1985 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 01/08/1985 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/13/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2023 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018760s044lbl.pdf | |
| 10/31/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf | |
| 08/21/2011 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf | |
| 10/29/2008 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf |
TENORETIC 100
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 |
TENORETIC 50
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 |