Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077877
Company: IPCA LABS LTD
Company: IPCA LABS LTD
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 |
---|---|---|---|---|---|---|---|
12/27/2006 | 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-18 | Labeling-Package Insert |
Label is not available on this site. |
||
11/07/2014 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
09/20/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
05/08/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/20/2015 | SUPPL-3 | 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 |