Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062432
Company: MYLAN
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 02/15/1983 | 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 |
|---|---|---|---|---|---|
| 09/05/2023 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2023 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2023 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2017 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2023 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2023 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2023 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/02/2014 | SUPPL-24 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/14/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/01/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/16/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/24/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/16/1991 | SUPPL-12 | Labeling |
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 |