Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205988
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;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 |
---|---|---|---|---|---|---|---|
03/10/2020 | ORIG-1 | Approval | 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 |
---|---|---|---|---|---|
10/30/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
VARDENAFIL HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL; 10MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 208324 | ALEMBIC |
VARDENAFIL HYDROCHLORIDE | VARDENAFIL HYDROCHLORIDE | 10MG | TABLET, ORALLY DISINTEGRATING;ORAL | Prescription | No | AB | 205988 | MACLEODS PHARMS LTD |