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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209937
Company: HIKMA

Products on ANDA 209937

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM TETRADECYL SULFATE	SODIUM TETRADECYL SULFATE	60MG/2ML (30MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209937

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/09/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209937

SODIUM TETRADECYL SULFATE

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

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