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PERPHENAZINE

ANDA

PERPHENAZINE | A207582 | WATSON LABORATORIES INC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs3 inactive

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

TRIFARMA SPAPERPHENAZINE USP

DMF 41301981

APICORE PHARMACEUTICALS PRIVATE LTDPERPHENAZINE USP

DMF 246462012

EMCURE PHARMACEUTICALS LTDPERPHENAZINE USP

DMF 272242013

MACLEODS PHARMACEUTICALS LTDPERPHENAZINE

DMF 307562016

JUBILANT BIOSYS LTDPERPHENAZINE USP

DMF 313792017

ORION CORP LTDInactivePERPHENAZINE

DMF 32731978

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactivePERPHENAZINE

DMF 66451986

FINE CHEMICALS CORPInactivePERPHENAZINE

DMF 85561990

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 19, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 17, 2016

No patent or exclusivity listings for this strength.

#002 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 17, 2016

#003 — 8MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 17, 2016

#004 — 16MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 17, 2016