Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200981
Company: RUBICON
Company: RUBICON
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 |
---|---|---|---|---|---|---|---|
10/28/2014 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/03/2019 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2016 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |