Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075666
Company: PADAGIS ISRAEL

Products on ANDA 075666

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075666

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75666ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2004	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075666

HYDROCORTISONE VALERATE

CREAM;TOPICAL; 0.2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	213724	COSETTE
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	211047	ENCUBE ETHICALS
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	211129	GLENMARK PHARMS LTD
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	210307	LUPIN LTD
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	075666	PADAGIS ISRAEL
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	CREAM;TOPICAL	Prescription	No	AB	075042	TARO