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APOMORPHINE HYDROCHLORIDE

ANDA

APOMORPHINE HYDROCHLORIDE | A212025 | TP ANDA HOLDINGS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: APOKYN(TE code: AP)

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

FRANCOPIA A EUROAPI COAPOMORPHINE HYDROCHLORIDE

DMF 128181998

MACFARLAN SMITH LTDAPOMORPHINE HYDROCHLORIDE

DMF 131881998

SUN PHARMACEUTICAL INDUSTRIES LTDAPOMORPHINE HYDROCHLORIDE USP

DMF 401982024

DIOSYNTH BVInactiveAPOMORPHINE HYDROCHLORIDE

DMF 89991991

LABORATOIRE AGUETTANT PARC SCIENTIFIC TONY GARNIER RUE ALEXANDER FLEMMINGInactiveAPOMORPHINE

DMF 93361991

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 9, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG/3ML (10MG/ML)

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Feb 23, 2022

No patent or exclusivity listings for this strength.