Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040541
Company: MYLAN INSTITUTIONAL

Products on ANDA 040541

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOTRADECOL	SODIUM TETRADECYL SULFATE	20MG/2ML (10MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	Yes
SOTRADECOL	SODIUM TETRADECYL SULFATE	60MG/2ML (30MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040541

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40541ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2019	SUPPL-15	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
03/01/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
05/30/2008	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040541

SOTRADECOL

INJECTABLE;INJECTION; 60MG/2ML (30MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM TETRADECYL SULFATE	SODIUM TETRADECYL SULFATE	60MG/2ML (30MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	209937	HIKMA
SOTRADECOL	SODIUM TETRADECYL SULFATE	60MG/2ML (30MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	040541	MYLAN INSTITUTIONAL