Application 213075
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 150MG BASE | No | No |
| 004 | DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | TABLET, DELAYED RELEASE;ORAL | EQ 200MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-481 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-482 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-483 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-484 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-481 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-481 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-482 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-482 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-483 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-483 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-484 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-484 | Doxycycline Hyclate | Doxycycline Hyclate | Alembic Pharmaceuticals Inc. | ANDA | Current |