Application 090431
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 75MG BASE | No | No |
| 002 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 100MG BASE | No | No |
| 003 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 50MG BASE | No | No |
| 004 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 80MG BASE | No | No |
| 005 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 200MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-4531 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4532 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4533 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4535 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4535 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4535 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-4535 | Doxycycline Hyclate | doxycycline hyclate | Mylan Pharmaceuticals Inc. | ANDA | Current |