Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076704
Company: MYLAN
Company: MYLAN
| 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 | Yes |
| 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 |
|---|---|---|---|---|---|---|---|
| 01/16/2004 | 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 |
|---|---|---|---|---|---|
| 06/03/2024 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2024 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2015 | SUPPL-21 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/06/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2010 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/21/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/16/2008 | SUPPL-9 | 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 RESEARCH |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET;ORAL | Prescription | No | AB | 208955 | SCIEGEN PHARMS |
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 RESEARCH |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 208955 | SCIEGEN PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS 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 RESEARCH |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 208955 | SCIEGEN PHARMS |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET;ORAL | Prescription | No | AB | 074644 | SUN PHARM INDS 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 RESEARCH |
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 RESEARCH |