Drugs@FDA: FDA-Approved Drugs
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/07/1984 | 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 |
|---|---|---|---|---|---|
| 07/26/2023 | SUPPL-77 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-74 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-72 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2018 | SUPPL-67 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-56 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2023 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-52 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-51 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2015 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2010 | SUPPL-42 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2010 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/30/2008 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/31/2007 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/08/2006 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 10/04/2004 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 10/24/2003 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/2002 | SUPPL-32 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/22/2001 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/25/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/05/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 062031 | ACTAVIS LABS FL INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210527 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207289 | AMNEAL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 209402 | CHANGZHOU PHARM |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062500 | CHARTWELL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062396 | HIKMA INTL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062676 | SUN PHARM INDUSTRIES |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207774 | ZYDUS LIFESCIENCES |
| VIBRAMYCIN | DOXYCYCLINE HYCLATE | EQ 100MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 050007 | PFIZER |
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 062031 | ACTAVIS LABS FL INC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 210527 | ALEMBIC |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062500 | CHARTWELL |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062396 | HIKMA INTL PHARMS |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 062676 | SUN PHARM INDUSTRIES |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 207774 | ZYDUS LIFESCIENCES |