Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | GRANULE;ORAL | EQ 125MG BASE/PACKET | 1 | LAMISIL | TERBINAFINE HYDROCHLORIDE |
| 002 | GRANULE;ORAL | EQ 187.5MG BASE/PACKET | 1 | LAMISIL | TERBINAFINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2007-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2010-12-02 | UNKNOWN |
| LABELING; Labeling | SUPPL | 4 | AP | 2011-03-30 | UNKNOWN |
| LABELING; Labeling | SUPPL | 6 | AP | 2011-11-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2012-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2013-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-10-23 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2016-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-01-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-03-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 8 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 31 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 15 | Null | 31 |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 22071
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)