Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089098
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/18/1985 | 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 |
|---|---|---|---|---|---|
| 01/29/2013 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2014 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/01/2010 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/11/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/15/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL; 100MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 200737 | ALKEM LABS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 203845 | CADILA PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 090527 | GLENMARK PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 086242 | HERITAGE PHARMS |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 040858 | HERITAGE PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 040901 | HETERO LABS LTD III |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 089098 | PLIVA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 205236 | SCIEGEN PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 088391 | STRIDES PHARMA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AA | 200770 | STRIDES PHARMA |