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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078104
Company: PERRIGO PHARMA INTL

Products on ANDA 078104

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078104

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078104s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2020	SUPPL-17	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/25/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/12/2020	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
11/14/2014	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.

Labels for ANDA 078104

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078104lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

TRIAMCINOLONE ACETONIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.055MG/SPRAY

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NASACORT ALLERGY 24 HOUR	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	Yes	020468	CHATTEM SANOFI
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	214615	APOTEX
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Over-the-counter	No	078104	PERRIGO PHARMA INTL

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