Application Sponsors
| ANDA 079012 | TIME-CAP LABS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 500MG BASE | 0 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 1GM BASE | 0 | VALACYCLOVIR HYDROCHLORIDE | VALACYCLOVIR HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2010-05-24 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-01-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-03-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
TIME-CAP LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 79012
[companyName] => TIME-CAP LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALACYCLOVIR HYDROCHLORIDE","activeIngredients":"VALACYCLOVIR HYDROCHLORIDE","strength":"EQ 1GM BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VALACYCLOVIR HYDROCHLORIDE","submission":"VALACYCLOVIR HYDROCHLORIDE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)