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SOTRADECOL

NDA

SODIUM TETRADECYL SULFATE | N005970 | ELKINS SINN DIV AH ROBINS CO INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Products (2)

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#004 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#005 — 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982