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HALOPERIDOL DECANOATE

ANDA

HALOPERIDOL DECANOATE | A075440 | MYLAN LABORATORIES LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs2 inactive

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

JANSSEN PHARMACEUTICA NVHALOPERIDOL DECANOATE

DMF 109541994

TAPI NL BVHALOPERIDOL DECANOATE

DMF 125301997

OLON SPAHALOPERIDOL DECANOATE

DMF 169492003

MSN LIFE SCIENCES PRIVATE LTDHALOPERIDOL DECANOATE USP

DMF 337032019

MANKIND PHARMA LTDHALOPERIDOL DECANOATE USP

DMF 343532020

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveHALOPERIDOL DECANOATE

DMF 66821986

EXCELLA GMBHInactiveHALOPERIDOL DECANOATE

DMF 191972006

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 9, 2008	SUPPL -23	View Letter (PDF)
Feb 28, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 28, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 28, 2000