Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075768
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | AB | No | No |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | AB | No | No |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | 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 |
---|---|---|---|---|---|---|---|
09/25/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75768ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/25/2024 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
02/07/2022 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
02/07/2022 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
06/02/2015 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/24/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 2.5MG;6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215666 | CADILA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | EPIC PHARMA LLC |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215995 | GLENMARK PHARMS LTD |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215562 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |
TABLET;ORAL; 5MG;6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215666 | CADILA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | EPIC PHARMA LLC |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215995 | GLENMARK PHARMS LTD |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215562 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |
TABLET;ORAL; 10MG;6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215666 | CADILA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | EPIC PHARMA LLC |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215995 | GLENMARK PHARMS LTD |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 215562 | NOVITIUM PHARMA |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |