Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075508
Company: TARO

Products on ANDA 075508

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIFLORASONE DIACETATE	DIFLORASONE DIACETATE	0.05%	CREAM;TOPICAL	Prescription	BX	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075508

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75508ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2016	SUPPL-14	Labeling-Proprietary Name Change		Label is not available on this site.
07/28/2016	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/15/2001	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
12/29/2000	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075508

DIFLORASONE DIACETATE

There are no Therapeutic Equivalents.