Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090615
Company: WOCKHARDT
Company: WOCKHARDT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
07/22/2010 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090615Orig1s000BioeqR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/17/2019 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL; EQ 25MG TARTRATE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204161 | ACTAVIS ELIZABETH |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211143 | ALKEM LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090617 | DR REDDYS LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216916 | GRANULES |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205541 | HETERO LABS LTD III |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202033 | MYLAN PHARMS INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204106 | NOVAST LABS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203028 | PHARMADAX INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214004 | SUNSHINE |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207206 | VISUM PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090615 | WOCKHARDT |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213854 | YICHANG HUMANWELL |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203894 | ZYDUS PHARMS |
TOPROL-XL | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019962 | TOPROL |
TABLET, EXTENDED RELEASE;ORAL; EQ 50MG TARTRATE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204161 | ACTAVIS ELIZABETH |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076862 | ACTAVIS LABS FL INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211143 | ALKEM LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207465 | CIPLA |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090617 | DR REDDYS LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216916 | GRANULES |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205541 | HETERO LABS LTD III |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202033 | MYLAN PHARMS INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204106 | NOVAST LABS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203028 | PHARMADAX INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214004 | SUNSHINE |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207206 | VISUM PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090615 | WOCKHARDT |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213854 | YICHANG HUMANWELL |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214110 | ZHEJIANG JUTAI PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203894 | ZYDUS PHARMS |
TOPROL-XL | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019962 | TOPROL |
TABLET, EXTENDED RELEASE;ORAL; EQ 100MG TARTRATE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204161 | ACTAVIS ELIZABETH |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211143 | ALKEM LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207465 | CIPLA |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216916 | GRANULES |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205541 | HETERO LABS LTD III |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202033 | MYLAN PHARMS INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204106 | NOVAST LABS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203699 | PHARMADAX INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078889 | REDDYS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214004 | SUNSHINE |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207206 | VISUM PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090615 | WOCKHARDT |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213854 | YICHANG HUMANWELL |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214110 | ZHEJIANG JUTAI PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203894 | ZYDUS PHARMS |
TOPROL-XL | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019962 | TOPROL |
TABLET, EXTENDED RELEASE;ORAL; EQ 200MG TARTRATE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204161 | ACTAVIS ELIZABETH |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 211143 | ALKEM LABS LTD |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207465 | CIPLA |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216916 | GRANULES |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205541 | HETERO LABS LTD III |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202033 | MYLAN PHARMS INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204106 | NOVAST LABS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203699 | PHARMADAX INC |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078889 | REDDYS |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214004 | SUNSHINE |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207206 | VISUM PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090615 | WOCKHARDT |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213854 | YICHANG HUMANWELL |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214110 | ZHEJIANG JUTAI PHARM |
METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203894 | ZYDUS PHARMS |
TOPROL-XL | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019962 | TOPROL |