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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091496
Company: PADAGIS ISRAEL

Products on ANDA 091496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/20/2013	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091496Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 091496

NITROGLYCERIN

SPRAY, METERED;SUBLINGUAL; 0.4MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITROGLYCERIN	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED;SUBLINGUAL	Prescription	No	AB	091496	PADAGIS ISRAEL
NITROLINGUAL PUMPSPRAY	NITROGLYCERIN	0.4MG/SPRAY	SPRAY, METERED;SUBLINGUAL	Prescription	Yes	AB	018705	POHL BOSKAMP

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