Application Sponsors
| ANDA 201022 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 125MG | 0 | FAMCICLOVIR | FAMCICLOVIR |
| 002 | TABLET;ORAL | 250MG | 0 | FAMCICLOVIR | FAMCICLOVIR |
| 003 | TABLET;ORAL | 500MG | 0 | FAMCICLOVIR | FAMCICLOVIR |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2012-01-12 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-05-30 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2019-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-07-25 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 14 | Null | 15 |
| SUPPL | 22 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201022
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/12\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/25\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/25\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/19\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/30\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-25
)
)