FdaApplication
NDA 050795
Identifiers
- fda_app_no: NDA050795
Properties
| Property | Value |
|---|---|
| applicant_name | MAYNE PHARMA INTERNATIONAL PTY LTD |
| application_type | NDA |
| approval_date | 2005-05-06 |
Products (8)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DORYX | DOXYCYCLINE HYCLATE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
| DORYX | DOXYCYCLINE HYCLATE | EQ 80MG BASE | TABLET, DELAYED RELEASE;ORAL |
| DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL |
| DORYX | DOXYCYCLINE HYCLATE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
| DORYX | DOXYCYCLINE HYCLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
| DORYX | DOXYCYCLINE HYCLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
| DORYX MPC | DOXYCYCLINE HYCLATE | EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
| DORYX MPC | DOXYCYCLINE HYCLATE | EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL |
8 products