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PITAVASTATIN CALCIUM

ANDA

PITAVASTATIN CALCIUM | A205977 | HETERO LABS LTD UNIT V

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LIVALO(TE code: AB)

API Supply Chain14 active DMFs2 inactive

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

NISSAN CHEMICAL CORPPITAVASTATIN CALCIUM

DMF 146602000

MSN LABORATORIES PRIVATE LTDPITAVASTATIN CALCIUM (PENTAHYDRATE)

DMF 234882010

SOLARA ACTIVE PHARMA SCIENCES LTDPITAVASTATIN CALCIUM

DMF 259562012

APITORIA PHARMA PRIVATE LTDPITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)

DMF 271062013

MATRIX PHARMACORP PRIVATE LTDPITAVASTATIN CALCIUM

DMF 271442013

LUPIN LTDPITAVASTATIN CALCIUM

DMF 272422013

HETERO DRUGS LTDPITAVASTATIN CALCIUM

DMF 272552013

ZYDUS LIFESCIENCES LTDPITAVASTATIN CALCIUM

DMF 273332013

NISSAN CHEMICAL CORPPITAVASTATIN CALCIUM (ASYMMETRIC SYNTHESIS METHOD)

DMF 277612013

KOLON LIFE SCIENCE INCPITAVASTATIN CALCIUM

DMF 321692018

WANBANG BIOPHARMACEUTICALSPITAVASTATIN CALCIUM

DMF 323452017

FUXIN LONG RUI PHARMACEUTICAL CO LTDPITAVASTATIN CALCIUM

DMF 334892019

APITORIA PHARMA PRIVATE LTDPITAVASTATIN CALCIUM (PROCESS-II)

DMF 413302025

FORMOSA LABORATORIES INCPITAVASTATIN CALCIUM HYDRATE

DMF 425302025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePITAVASTATIN CALCIUM

DMF 264062012

JILIN ASYMCHEM LABORATORIES CO LTDInactivePITAVASTATIN CALCIUM

DMF 283842014

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 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 30, 2024

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 30, 2024

#003 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 30, 2024