Drugs@FDA: FDA-Approved Drugs
Company: CARIBE HOLDINGS
| 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 | Yes |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG 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 |
|---|---|---|---|---|---|---|---|
| 11/08/1982 | 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 |
|---|---|---|---|---|---|
| 09/08/2020 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2016 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2014 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/22/2013 | SUPPL-21 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/18/2003 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/26/2002 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/2002 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/17/2001 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-1 | 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 |
TABLET;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;ORAL | Prescription | No | AB | 210536 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 062269 | CARIBE HOLDINGS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | TABLET;ORAL | Prescription | No | AB | 062505 | CHARTWELL |