Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018240
Company: TWI PHARMS
Company: TWI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TENORMIN | ATENOLOL | 50MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TENORMIN | ATENOLOL | 100MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| TENORMIN | ATENOLOL | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018240s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018240Orig1s047ltr.pdf | |
| 09/10/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/2015 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/2015 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2012 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018240Orig1s032ltr.pdf | |
| 08/17/2011 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018240s031ltr.pdf | |
| 04/29/2008 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018240s030ltr.pdf |
| 02/09/2005 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18240s029ltr.pdf |
| 11/06/2003 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf |
| 01/09/2003 | SUPPL-27 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr027ltr.pdf |
| 07/21/1999 | SUPPL-26 | 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-25 | 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-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/04/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/29/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/05/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/05/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/18/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/09/1990 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 02/13/1987 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/18/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/19/1984 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/12/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1983 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1989 | SUPPL-5 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/27/1983 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/07/1983 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/04/1985 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/23/1981 | SUPPL-1 | Labeling |
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-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018240s047lbl.pdf | |
| 10/31/2012 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf | |
| 08/17/2011 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf |
TENORMIN
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 072304 | AIPING PHARM INC |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077877 | IPCA LABS LTD |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 073457 | MYLAN |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 073026 | PHARMOBEDIENT |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 213136 | UNICHEM |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077443 | UNIQUE |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 076900 | ZYDUS PHARMS USA |
| TENORMIN | ATENOLOL | 50MG | TABLET;ORAL | Prescription | Yes | AB | 018240 | TWI PHARMS |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 072304 | AIPING PHARM INC |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077877 | IPCA LABS LTD |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 073457 | MYLAN |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 073026 | PHARMOBEDIENT |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 213136 | UNICHEM |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077443 | UNIQUE |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 076900 | ZYDUS PHARMS USA |
| TENORMIN | ATENOLOL | 100MG | TABLET;ORAL | Prescription | Yes | AB | 018240 | TWI PHARMS |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 072304 | AIPING PHARM INC |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077877 | IPCA LABS LTD |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 073457 | MYLAN |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 073026 | PHARMOBEDIENT |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 213136 | UNICHEM |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 077443 | UNIQUE |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 076900 | ZYDUS PHARMS USA |
| TENORMIN | ATENOLOL | 25MG | TABLET;ORAL | Prescription | Yes | AB | 018240 | TWI PHARMS |