Application 207494
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 150MG BASE | No | No |
| 002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 200MG BASE | No | No |
| 003 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 50MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-324 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-324 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-324 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-324 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-325 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-325 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-325 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-325 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-462 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-462 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 43547-462 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | Solco Healthcare US LLC | ANDA | Current |
| 69668-515 | Doxycycline Hyclate | DOXYCYCLINE HYCLATE | Sonoma Pharmaceuticals, Inc. | ANDA | Current |