Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019962
Company: TOPROL
Company: TOPROL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPROL-XL | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| TOPROL-XL | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| TOPROL-XL | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| TOPROL-XL | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 01/10/1992 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/10/2023 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019962s050s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019962Orig1s050,s052ltr.pdf | |
| 03/10/2023 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019962s050s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019962Orig1s050,s052ltr.pdf | |
| 06/01/2022 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019962Orig1s049ltr.pdf | |
| 01/12/2022 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019962Orig1s048ltr.pdf | |
| 05/12/2014 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2014 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019962Orig1s044ltr.pdf | |
| 10/31/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019962Orig1s043ltr.pdf | |
| 01/19/2010 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s042ltr.pdf | |
| 03/19/2010 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s041ltr.pdf | |
| 02/12/2009 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019962s038ltr.pdf | |
| 02/15/2008 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019962s036ltr.pdf | |
| 03/14/2007 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s034ltr.pdf |
| 07/18/2007 | SUPPL-33 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s033ltr.pdf | |
| 07/27/2006 | SUPPL-32 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s032LTR.pdf | |
| 05/04/2006 | SUPPL-31 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s031LTR.pdf |
| 04/05/2005 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s028ltr.pdf |
| 02/15/2005 | SUPPL-27 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s027ltr.pdf | |
| 01/27/2003 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962slr024ltr.pdf |
| 03/05/2002 | SUPPL-22 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962s22ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-962S022.pdf |
| 10/25/2001 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/22/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2001 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/26/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/2001 | SUPPL-13 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol.cfm | |
| 03/05/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/25/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/12/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/27/1994 | SUPPL-4 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-004_Toprol_XL.pdf |
| 03/04/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-003_Toprol_XL.pdf |
| 06/24/1992 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-002_Toprol_XL.pdf |
| 02/27/1992 | SUPPL-1 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-001_Toprol_XL.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/10/2023 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019962s050s052lbl.pdf | |
| 03/10/2023 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019962s050s052lbl.pdf | |
| 06/01/2022 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s049lbl.pdf | |
| 01/12/2022 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019962s048lbl.pdf | |
| 05/06/2014 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf | |
| 10/31/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf | |
| 03/19/2010 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf | |
| 01/19/2010 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf | |
| 02/12/2009 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf | |
| 02/15/2008 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf | |
| 07/18/2007 | SUPPL-33 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf | |
| 07/27/2006 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf | |
| 07/27/2006 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf | |
| 02/15/2005 | SUPPL-27 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf | |
| 02/05/2001 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf |
TOPROL-XL
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 | 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 | 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 | 203894 | ZYDUS PHARMS |
| TOPROL-XL | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019962 | TOPROL |
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 | 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 |