Application Sponsors
ANDA 087881 | WOCKHARDT BIO AG | |
Marketing Status
Application Products
001 | SOLUTION;TOPICAL | 4% | 0 | LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1982-11-18 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1987-05-14 | |
LABELING; Labeling | SUPPL | 7 | AP | 1989-09-06 | |
LABELING; Labeling | SUPPL | 8 | AP | 1992-05-28 | |
LABELING; Labeling | SUPPL | 9 | AP | 1994-02-16 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-04-15 | UNKNOWN |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-08-13 | |
LABELING; Labeling | SUPPL | 12 | AP | 2015-10-19 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 15 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 87881
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)