Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
| DOXYCYCLINE HYCLATE | DOXYCYCLINE HYCLATE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1984 | 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 |
|---|---|---|---|---|---|
| 07/21/2021 | SUPPL-56 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/21/2021 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2021 | SUPPL-52 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/02/2014 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2008 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 03/28/2006 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/26/2005 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/27/2004 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-23 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
DOXYCYCLINE HYCLATE
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 |
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 |