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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075043
Company: SUN PHARMA CANADA

Products on ANDA 075043

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/2003	SUPPL-5	Labeling		Label is not available on this site.
07/29/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
04/27/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/21/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 075043

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/75043_Hydrocortisone%20Valerate_prntlbl.pdf

Therapeutic Equivalents for ANDA 075043

HYDROCORTISONE VALERATE

OINTMENT;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%	OINTMENT;TOPICAL	Prescription	No	AB	211764	COSETTE
HYDROCORTISONE VALERATE	HYDROCORTISONE VALERATE	0.2%	OINTMENT;TOPICAL	Prescription	No	AB	075043	SUN PHARMA CANADA

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