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CORPHED

ANDA

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE | A088602 | CHARTWELL RX SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara P.C. FDA-2019-P-3903 · 4 docket documents Hyman, Phelps & McNamara P.C. filed this citizen petition requesting that the FDA designate ANDA 040014 (Lidocaine Hydrochloride Oral Solution, 2%, held by Hi-Tech Pharmaceuticals) as a new reference standard in the Orange Book to replace the currently unavailable reference standard approved under A	505(q)	2019-08-20	Granted	Hyman, Phelps & McNamara P.C.

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

API Supply Chain1 active DMF

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

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHPSEUDOEPHEDRINE

DMF 41851981

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

Products (1)

#001 — 60MG;2.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 11, 1985

No patent or exclusivity listings for this strength.