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METHOXSALEN

ANDA

METHOXSALEN | A202687 | ONESOURCE SPECIALTY PTE LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: OXSORALEN-ULTRA(TE code: AB)

API Supply Chain2 active DMFs4 inactive

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

WANBURY LTDMETHOXSALEN

DMF 200382006

SOLARA ACTIVE PHARMA SCIENCES LTDMETHOXSALEN USP

DMF 218622008

MEMPHIS CHEMICAL COInactiveMETHOXSALEN USP

DMF 29341977

FRANCO INDIAN PHARMACEUTICALS PVT LTDInactiveMETHOXSALEN

DMF 35641979

OY STAR ABInactiveMETHOXSALEN

DMF 47921983

CHEMPACIFIC CORPInactiveMETHOXSALEN DRUG SUBSTANCE

DMF 193502006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 10, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 5, 2014

No patent or exclusivity listings for this strength.