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TRIAZOLAM

ANDA

TRIAZOLAM | A074031 | PHARMOBEDIENT CONSULTING LLC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a	Other	2015-12-16	Open	Daniel F. Kripke, MD (The Weston Firm)

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

API Supply Chain2 active DMFs5 inactive

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

CAMBREX PROFARMACO MILANO SRLTRIAZOLAM

DMF 87041990

CENTAUR PHARMACEUTICALS PRIVATE LTDTRIAZOLAM USP

DMF 359222021

DIOSYNTH BVInactiveTRIAZOLAM

DMF 86241990

ZAMBON SPAInactiveTRIAZOLAM

DMF 88591990

ORION CORP LTDInactiveTRIAZOLAM

DMF 92001991

FINE CHEMICALS CORPInactiveTRIAZOLAM

DMF 93421991

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveTRIAZOLAM USP MICRONIZED

DMF 243142010

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

Products (2)

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#001 — 0.125MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 25, 1994

No patent or exclusivity listings for this strength.

#002 — 0.25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 25, 1994