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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089884
Company: ZYDUS PHARMS

Products on ANDA 089884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089884

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/98/89884_Nitroglycerin%20Transdermal_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/89884ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/089884_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.

Labels for ANDA 089884

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/98/89884_Nitroglycerin%20Transdermal_Prntlbl.pdf

Therapeutic Equivalents for ANDA 089884

NITROGLYCERIN

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	074559	MYLAN TECHNOLOGIES
NITROGLYCERIN	NITROGLYCERIN	0.2MG/HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription	No	AB2	089884	ZYDUS PHARMS

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