Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076792
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | AB | No | No |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;100MG | TABLET;ORAL | Prescription | AB | No | No |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 50MG;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 |
---|---|---|---|---|---|---|---|
08/20/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76792ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/2024 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
08/10/2023 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
08/10/2023 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
08/10/2023 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
06/04/2010 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 25MG;50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOPRESSOR HCT | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | Yes | AB | 018303 | VALIDUS PHARMS |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | No | AB | 202870 | ALEMBIC |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET;ORAL | Prescription | No | AB | 076792 | MYLAN |
TABLET;ORAL; 25MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 202870 | ALEMBIC |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;100MG | TABLET;ORAL | Prescription | No | AB | 076792 | MYLAN |
TABLET;ORAL; 50MG;100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 50MG;100MG | TABLET;ORAL | Prescription | No | AB | 202870 | ALEMBIC |
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 50MG;100MG | TABLET;ORAL | Prescription | No | AB | 076792 | MYLAN |