Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS FL INC
| 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 |
|---|---|---|---|---|---|---|---|
| 10/13/1982 | 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 |
|---|---|---|---|---|---|
| 05/17/2021 | SUPPL-82 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/17/2021 | SUPPL-81 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2018 | SUPPL-80 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2018 | SUPPL-79 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2014 | SUPPL-74 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/28/2010 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 09/01/2005 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 12/23/2002 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 02/20/2002 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 04/25/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/08/2001 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 06/16/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/14/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/23/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/26/1992 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 11/15/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1988 | SUPPL-16 | 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 |