Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200790
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/04/2014 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200790Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/12/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/28/2016 | SUPPL-1 | 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 | HOFFMANN LA ROCHE |
| 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 | 209672 | CIPLA |
| 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 |