Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086242
Company: HERITAGE PHARMS
Company: HERITAGE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AA | No | No |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AA | No | No |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AA | No | No |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/1978 | 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 |
|---|---|---|---|---|---|
| 02/04/2010 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/02/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 200737 | ALKEM LABS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 090527 | GLENMARK PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 086242 | HERITAGE PHARMS |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 040858 | HERITAGE PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 040901 | HETERO LABS LTD III |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 089097 | PLIVA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 205236 | SCIEGEN PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AA | 087836 | STRIDES PHARMA |
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 |
TABLET;ORAL; 25MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 200737 | ALKEM LABS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 203845 | CADILA PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 090527 | GLENMARK PHARMS LTD |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 086242 | HERITAGE PHARMS |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 040858 | HERITAGE PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 040901 | HETERO LABS LTD III |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AA | 088467 | PLIVA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 205236 | SCIEGEN PHARMS INC |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 086961 | STRIDES PHARMA |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AA | 200770 | STRIDES PHARMA |
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 |