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ASENAPINE MALEATE

ANDA

ASENAPINE MALEATE | A206098 | ALEMBIC PHARMACEUTICALS LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SAPHRIS(TE code: AB)

API Supply Chain10 active DMFs3 inactive

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

DR REDDYS LABORATORIES LTDASENAPINE MALEATE

DMF 257452012

OLON SPAASENAPINE MALEATE

DMF 261042012

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE AN]

DMF 267852013

MSN ORGANICS PRIVATE LTDASENAPINE MALEATE [ROUTE CODE "AOI"]

DMF 269732013

MATRIX PHARMACORP PRIVATE LTDASENAPINE MALEATE

DMF 270862013

SUN PHARMACEUTICAL INDUSTRIES LTDASENAPINE MALEATE

DMF 271852013

ALEMBIC PHARMACEUTICALS LTDASENAPINE MALEATE

DMF 271942013

MEGAFINE PHARMA P LTDASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE)

DMF 272922013

SIGMAPHARM LABORATORIES LLCASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX

DMF 273002013

ASPEN OSS BVASENAPINE MALEATE

DMF 348682020

LUPIN LTDInactiveASENAPINE MALEATE (MICRONIZED)

DMF 272852013

CHEMO IBERICA SAInactiveASENAPINE MALEATE

DMF 272902013

SIGNA SA DE CVInactiveASENAPINE MALEATE

DMF 273162013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Dec 10, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Dec 10, 2020

#003 — EQ 2.5MG BASE

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: Jul 19, 2021