Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203511
Company: DR REDDYS LABS LTD
Company: DR REDDYS LABS LTD
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 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203511Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/13/2020 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
03/13/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
08/22/2016 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient 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 | 206876 | DR REDDYS |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 203511 | DR REDDYS LABS LTD |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 200790 | ENDO PHARMS INC |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | EQ 450MG BASE | TABLET;ORAL | Prescription | No | AB | 205166 | HETERO LABS LTD V |
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