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ALPRAZOLAM

ANDA

ALPRAZOLAM | A078088 | PH HEALTH LTD

4 strengths0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs9 inactive

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

CAMBREX PROFARMACO MILANO SRLALPRAZOLAM

DMF 70941987

FERMION OYALPRAZOLAM

DMF 90431991

PH HEALTH LTDALPRAZOLAM DRUG SUBSTANCE

DMF 180752005

MATRIX PHARMACORP PRIVATE LTDALPRAZOLAM USP

DMF 182142005

MALLADI DRUGS AND PHARMACEUTICALS LTDALPRAZOLAM

DMF 204482007

CENTAUR PHARMACEUTICALS PVT LTDALPRAZOLAM USP

DMF 208272007

RL FINE CHEM PVT LTDALPRAZOLAM

DMF 334172019

MATRIX PHARMACORP PRIVATE LTDALPRAZOLAM USP (FORM-III)

DMF 408612025

CIPLA LTDInactiveALPRAZOLAM USP

DMF 80601989

ZAMBON SPAInactiveALPRAZOLAM

DMF 88601990

DIOSYNTH BVInactiveALPRAZOLAM

DMF 91281991

FINE CHEMICALS CORPInactiveALPRAZOLAM

DMF 93431991

LAKE CHEMICALS PRIVATE LTDInactiveALPRAZOLAM

DMF 218282008

ALP PHARM BEIJING CO LTDInactiveALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE)

DMF 219492008

QILU TIANHE PHARMACEUTICAL CO LTDInactiveALPRAZOLAM USP (NON STERILE API)

DMF 220362008

NOVUS FINE CHEMICALS LLCInactiveALPRAZOLAM (CIV)

DMF 231932009

APOTEX PHARMACHEM INDIA PVT LTDInactiveALPRAZOLAM USP

DMF 250742011

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 12, 2009	ORIG -1	View Letter (PDF)
Sep 25, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.25MG

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 9, 2009

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 9, 2009

#003 — 1MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 9, 2009

#004 — 2MG

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Jan 9, 2009