Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040901
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 | 25MG | TABLET;ORAL | Prescription | AA | No | No |
HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | 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 |
---|---|---|---|---|---|---|---|
09/12/2008 | 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 |
---|---|---|---|---|---|
01/05/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |
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 | 211010 | MACLEODS PHARMS LTD |
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; 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 |
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 | No | AA | 211010 | MACLEODS PHARMS LTD |
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; 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 |
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 | No | AA | 211010 | MACLEODS PHARMS LTD |
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; 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 |
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 | 211010 | MACLEODS PHARMS LTD |
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 |