Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205166
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG 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 |
---|---|---|---|---|---|---|---|
03/18/2016 | 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 |
---|---|---|---|---|---|
08/18/2022 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
08/18/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
03/12/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
VALGANCICLOVIR HYDROCHLORIDE
TABLET;ORAL; EQ 450MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021304 | CHEPLAPHARM |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 212234 | AJANTA PHARMA LTD |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 204750 | AUROBINDO PHARMA LTD |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 203511 | DR REDDYS |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 206876 | DR REDDYS |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 205166 | HETERO LABS LTD V |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 200790 | STRIDES PHARMA |