Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089885
Company: HERCON PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No No
NITROGLYCERIN NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 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
10/30/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89885_Nitroglycerin%20Transdermal_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089885_nitroglycerin_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2001 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/14/2001 SUPPL-3 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/14/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/89885_Nitroglycerin%20Transdermal_Prntlbl.pdf

NITROGLYCERIN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.4MG/HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 089885 HERCON PHARM
NITROGLYCERIN NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 074559 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 089885 HERCON PHARM
NITROGLYCERIN NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 074559 MYLAN TECHNOLOGIES

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