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TYZINE

ANDA

TETRAHYDROZOLINE HYDROCHLORIDE | A086576 | FOUGERA PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From the Madison Company FDA-2015-P-0233 · 10 docket documents Christine C. Oddo, doing business as Madison Company, submitted this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA permit marketing of Tetrahydrozoline Hydrochloride at concentrations of 0.01 to 0.05 percent in consumer cosmetic leave-on topic	Other	2015-01-28	Open	the Madison Company

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZENTIVA KSInactiveTETRAHYDROZOLINE HYDROCHLORIDE USP

DMF 151912000

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

Products (3)

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#001 — 0.1%

0 patents0 exclusivities▴

SOLUTION;NASAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.05%

0 patents0 exclusivities▾

SOLUTION;NASAL | Approved: Approved Prior to Jan 1, 1982

#003 — 0.1%

0 patents0 exclusivities▾

SPRAY;NASAL | Approved: Approved Prior to Jan 1, 1982