Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200856
Company: HERITAGE PHARMS
Company: HERITAGE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/30/2013 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
TABLET, DELAYED RELEASE;ORAL; EQ 75MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090134 | ACTAVIS ELIZABETH |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213075 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 75MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200856 | HERITAGE PHARMS |
TABLET, DELAYED RELEASE;ORAL; EQ 100MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090134 | ACTAVIS ELIZABETH |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213075 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200856 | HERITAGE PHARMS |
TABLET, DELAYED RELEASE;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213075 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200856 | HERITAGE PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 150MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 207494 | PRINSTON INC |
TABLET, DELAYED RELEASE;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DORYX | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | Yes | AB | 050795 | MAYNE PHARMA |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090134 | ACTAVIS ELIZABETH |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 213075 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 200856 | HERITAGE PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 207494 | PRINSTON INC |