Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077739
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | AB | No | No |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET;ORAL | Prescription | AB | No | No |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/2007 | 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 |
|---|---|---|---|---|---|
| 11/22/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2014 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/15/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/15/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
METOPROLOL TARTRATE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 202871 | ALEMBIC PHARMS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 078459 | IPCA LABS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 076670 | SUN PHARM INDS INC |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 208955 | YOUNGTECH PHARMS INC |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 017963 | VALIDUS PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 202871 | ALEMBIC PHARMS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 078459 | IPCA LABS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 074453 | RENATA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS INC |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 208955 | YOUNGTECH PHARMS INC |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPRESSOR | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 017963 | VALIDUS PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 202871 | ALEMBIC PHARMS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 078459 | IPCA LABS LTD |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 074453 | RENATA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS INC |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 208955 | YOUNGTECH PHARMS INC |
TABLET;ORAL; 37.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | TABLET;ORAL | Prescription | No | AB | 077739 | AUROBINDO PHARMA |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | TABLET;ORAL | Prescription | No | AB | 076704 | MYLAN |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | TABLET;ORAL | Prescription | No | AB | 200981 | RUBICON |