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ZIPRASIDONE HYDROCHLORIDE

ANDA

ZIPRASIDONE HYDROCHLORIDE | A204117 | AUROBINDO PHARMA LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: GEODON(TE code: AB)

API Supply Chain14 active DMFs6 inactive

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

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 179222004

APOTEX INCZIPRASIDONE HYDROCHLORIDE

DMF 180502005

LUPIN LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 180552005

WOCKHARDT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 195032006

ZYDUS LIFESCIENCES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 207692007

APITORIA PHARMA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 210122007

DR REDDYS LABORATORIES LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 211472007

MEGAFINE PHARMA P LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP (NON STERILE DRUG SUBSTANCE)

DMF 237392010

JUBILANT PHARMOVA LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 249552011

MACLEODS PHARMACEUTICALS LTDZIPRASIDONE HYDROCHLORIDE

DMF 250482011

AMINO CHEMICALS LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE

DMF 272592013

RAKS PHARMA PVT LTDZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP

DMF 311832016

APOTEX INCZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 331732018

CHROMO LABORATORIES INDIA PRIVATE LTDZIPRASIDONE HYDROCHLORIDE USP

DMF 339912019

RANBAXY LABORATORIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 180422005

CADILA HEALTHCARE LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 189522005

TEVA PHARMACEUTICALS INDUSTRIES LTDInactiveZIPRASIDONE HYDROCHLORIDE

DMF 190052005

AMINO CHEMICALS LTDInactiveZIPRASIDONE HYDROCHLORIDE ANHYDROUS

DMF 201052006

WATSON PHARMA PRIVATE LTDInactiveZIPRASIDONE HYDROCHLORIDE MONOHYDRATE USP

DMF 243472010

QILU TIANHE PHARMACEUTICAL CO LTDInactiveZIPRASIDONE HYDROCHLORIDE (NON - STERILE API)

DMF 248372011

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

Products (4)

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#001 — EQ 20MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 27, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 40MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 27, 2016

#003 — EQ 60MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 27, 2016

#004 — EQ 80MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 27, 2016