Up
2006P-0305:
Permit the Filing of an ANDA Suitability for Loperamide Hydrochloride
Orally Dissolving Strips, 2 mg
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
CP1 |
|
08/02/2006
|
|
08/02/2006
|
|
Private Industry
|
|
Monosol Rx,
LLC. |
|
|
|
|
|
|
|
Table
of Contents |
|
|
|
|
Signature: |
|
Pradeep Sanghvi Ph.D
|
|
|
|
ACK1 |
|
08/02/2006
|
|
08/02/2006
|
|
Federal Government |
|
FDA/ DDM to
Monosol Rx, LLC. |
|
|
|
|
|
|
|
pdf |
|
|
|
|
|
|
Signature: |
|
Gloria Ortega |
|
|
|
|
|
|
|
|
| C1
|
| 09/12/2006
|
| 09/02/2006
|
| Individual Consumer
|
| D. Lowe
|
|
|
|
|
|
|
|
|
|
|
|
| Signature:
|
| David Lowe
| |
|
|
|
|
|
|
|
Top | Up
Page last updated
October 27, 2006
kk
Dockets Home Page | Dockets
Contacts and Location | Operating
Status | Item
Code Definitions | Federal
Register
FDA Home Page | Search
FDA Site | FDA A-Z Index
| Contact FDA
FDA/Dockets Management |