Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073457
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATENOLOL | ATENOLOL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| ATENOLOL | ATENOLOL | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| ATENOLOL | ATENOLOL | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/24/1992 | 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 |
|---|---|---|---|---|---|
| 07/01/2015 | SUPPL-35 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/12/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/06/2004 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 10/28/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/03/2003 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/07/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1999 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 08/14/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/30/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/08/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/21/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/05/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/20/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
ATENOLOL
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 |
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 |