Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| 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 |
|---|---|---|---|---|---|---|---|
| 07/10/1986 | 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-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2021 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2018 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2018 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2018 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/15/2018 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/23/2015 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2013 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/28/2006 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/08/2006 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/06/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/01/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/26/2002 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/16/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/01/1989 | 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 |