Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074559
Company: MYLAN TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITROGLYCERIN NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No Yes
NITROGLYCERIN NITROGLYCERIN 0.4MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No Yes
NITROGLYCERIN NITROGLYCERIN 0.2MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No Yes
NITROGLYCERIN NITROGLYCERIN 0.1MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No 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
08/30/1996 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
07/15/2002 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/19/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/27/1999 SUPPL-3 Labeling

Label is not available on this site.

12/22/1998 SUPPL-2 Labeling

Label is not available on this site.

07/30/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NITROGLYCERIN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.6MG/HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 089886 HERCON PHARM
NITROGLYCERIN NITROGLYCERIN 0.6MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 074559 MYLAN TECHNOLOGIES

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; 0.2MG/HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NITROGLYCERIN NITROGLYCERIN 0.2MG/HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 089884 HERCON PHARM
NITROGLYCERIN NITROGLYCERIN 0.2MG/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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