Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205220
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
07/18/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205220Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/12/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
03/12/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION;ORAL; 50MG/ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VALCYTE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | Yes | AB | 022257 | CHEPLAPHARM |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 205220 | ACTAVIS LABS FL INC |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 212890 | AJANTA PHARMA LTD |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 216317 | APPCO |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 215124 | AUROBINDO PHARMA |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 213306 | GRANULES |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 211475 | HETERO LABS LTD V |
VALGANCICLOVIR HYDROCHLORIDE | VALGANCICLOVIR HYDROCHLORIDE | 50MG/ML | FOR SOLUTION;ORAL | Prescription | No | AB | 210169 | MSN |