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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020727
Company: AZURITY
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
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
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

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 215586 RICONPHARMA LLC
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