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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020727
Company: AZURITY

Products on NDA 020727

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIDIL	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020727

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2005	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020727lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020727ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020727_s000_BidilTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-12	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020727Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020727Orig1s012ltr.pdf
03/12/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020727s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020727Orig1s010ltr.pdf
06/14/2016	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/02/2015	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020727s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020727Orig1s005ltr.pdf
03/27/2013	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020727s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020727Orig1s004ltr.pdf

Labels for NDA 020727

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2021	SUPPL-12	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020727Orig1s012lbl.pdf
03/12/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020727s010lbl.pdf
04/02/2015	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020727s005lbl.pdf
03/27/2013	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020727s004lbl.pdf
06/23/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020727lbl.pdf

Therapeutic Equivalents for NDA 020727

BIDIL

TABLET;ORAL; 37.5MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIDIL	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	Yes	AB	020727	AZURITY
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	No	AB	215988	I3 PHARMS
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	No	AB	215586	RICONPHARMA LLC

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