Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091347
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | 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 |
---|---|---|---|---|---|---|---|
05/03/2012 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/07/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
10/30/2012 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
VARDENAFIL HYDROCHLORIDE
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 214031 | ALEMBIC |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 209057 | CROSSMEDIKA SA |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 204632 | MACLEODS PHARMS LTD |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 091347 | TEVA PHARMS |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 208960 | ZYDUS PHARMS |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 214031 | ALEMBIC |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 209057 | CROSSMEDIKA SA |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 204632 | MACLEODS PHARMS LTD |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 091347 | TEVA PHARMS |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 208960 | ZYDUS PHARMS |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214031 | ALEMBIC |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209057 | CROSSMEDIKA SA |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204632 | MACLEODS PHARMS LTD |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091347 | TEVA PHARMS |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 208960 | ZYDUS PHARMS |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214031 | ALEMBIC |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 209057 | CROSSMEDIKA SA |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 204632 | MACLEODS PHARMS LTD |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091347 | TEVA PHARMS |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 208960 | ZYDUS PHARMS |