Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086962
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 02/27/1980 | 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 |
|---|---|---|---|---|---|
| 12/11/2001 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 07/14/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/07/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 200737 | ALKEM LABS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 203845 | CADILA PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 090527 | GLENMARK PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 086242 | HERITAGE PHARMS |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040858 | HERITAGE PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 040901 | HETERO LABS LTD III |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AA | 088468 | PLIVA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 205236 | SCIEGEN PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 086962 | STRIDES PHARMA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AA | 200770 | STRIDES PHARMA |