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APRACLONIDINE HYDROCHLORIDE

ANDA

APRACLONIDINE HYDROCHLORIDE | A077764 | RISING PHARMA HOLDINGS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: IOPIDINE(TE code: AT)

API Supply Chain2 active DMFs

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

PCASAPRACLONIDINE HYDROCHLORIDE

DMF 166012003

FORMOSA LABORATORIES INCAPRACLONIDINE HYDROCHLORIDE

DMF 167682003

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 17, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.5% BASE

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Mar 12, 2009

No patent or exclusivity listings for this strength.