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SOTRADECOL

ANDA

SODIUM TETRADECYL SULFATE | A040541 | MYLAN INSTITUTIONAL LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CHEMWERTH INCSODIUM TETRADECYL SULFATE (STDS)(NON-STERILE BULK DRUG SUBSTANCE)

DMF 164832003

AGNO PHARMASODIUM TETRADECYL SULFATE

DMF 309002016

STD PHARMACEUTICAL PRODUCTS LTDSODIUM TETRADECYL SULFATE CONCENTRATE 50%

DMF 312102017

STD PHARMACEUTICAL PRODUCTS LTDSODIUM TETRADECYL SULFATE INJECTION 1% AND 3%

DMF 312122017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 16, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MG/2ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 12, 2004

No patent or exclusivity listings for this strength.

#002 — 60MG/2ML (30MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 12, 2004