Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/02/1983 | 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 |
|---|---|---|---|---|---|
| 05/17/2021 | SUPPL-70 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2021 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2018 | SUPPL-68 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2018 | SUPPL-67 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2018 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/14/2012 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2010 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2001 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/26/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/01/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/14/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/23/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/26/1992 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/15/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
TABLET;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;ORAL | Prescription | No | AB | 210664 | ACELLA |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 062421 | ACTAVIS LABS FL INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 062269 | CARIBE HOLDINGS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 211343 | CHANGZHOU PHARM |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 062505 | CHARTWELL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 065095 | HIKMA INTL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 062432 | MYLAN |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 209560 | NOSTRUM LABS INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 207558 | NOVEL LABS INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 062677 | SUN PHARM INDUSTRIES |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | TABLET;ORAL | Prescription | No | AB | 207773 | ZYDUS LIFESCIENCES |