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 | 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 |
|---|---|---|---|---|---|---|---|
| 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. |
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| 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. |
||
| 09/10/2015 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/24/2013 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/30/2011 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/29/2008 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 09/28/2006 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/08/2006 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 07/06/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 04/01/2003 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 02/26/2002 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/12/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/16/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/26/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/12/1993 | 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
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 |