Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090134
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| 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 50MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 200MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/14/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2024 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2021 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2018 | SUPPL-18 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090134Orig1s018ltr.pdf | |
| 12/27/2017 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2017 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/27/2017 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2014 | SUPPL-11 | Labeling-Package Insert |
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 50MG 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 50MG BASE | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 090134 | ACTAVIS ELIZABETH |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG 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 |