Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076900
Company: ZYDUS PHARMS USA
Company: ZYDUS PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| ATENOLOL | ATENOLOL | 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 |
|---|---|---|---|---|---|---|---|
| 01/28/2005 | 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 |
|---|---|---|---|---|---|
| 03/28/2024 | SUPPL-31 | Labeling-Package Insert, Labeling |
Label is not available on this site. |
||
| 10/31/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/13/2011 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 08/29/2008 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/19/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/19/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/19/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/01/2007 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/2007 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/2007 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 07/17/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
ATENOLOL
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 | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 073026 | HLTHCARE |
| 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 | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | No | AB | 072304 | TWI PHARMS |
| 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 |
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 | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 073026 | HLTHCARE |
| 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 | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 50MG | TABLET;ORAL | Prescription | No | AB | 072304 | TWI PHARMS |
| 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 | 078512 | AUROBINDO PHARMA |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 073026 | HLTHCARE |
| 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 | 074056 | TEVA |
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | No | AB | 072304 | TWI PHARMS |
| 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 |