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PRAVASTATIN SODIUM

ANDA

PRAVASTATIN SODIUM | A209869 | BIOCON PHARMA INC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs9 inactive

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

TAPI NL BVPRAVASTATIN SODIUM

DMF 147292000

BIOCON LTDPRAVASTATIN SODIUM USP

DMF 160482002

APOTEX PHARMACHEM INCPRAVASTATIN SODIUM

DMF 170232003

BIOCON LTDPRAVASTATIN SODIUM

DMF 174472004

CONCORD BIOTECH LTDPRAVASTATIN SODIUM USP

DMF 207272007

ZHEJIANG HISUN PHARMACEUTICAL CO LTDPRAVASTATIN SODIUM USP (PROCESS II)

DMF 276152013

DAIICHI SANKYO CO LTDInactivePRAVASTATIN SODIUM DRUG SUBSTANCE

DMF 75681988

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactivePRAVASTATIN SODIUM USP

DMF 142351999

LEK PHARMACEUTICALS DDInactivePRAVASTATIN SODIUM

DMF 159222002

RANBAXY LABORATORIES LTDInactivePRAVASTATIN SODIUM

DMF 160312002

LEK PHARMACEUTICALS DDInactivePRAVASTATIN SODIUM

DMF 162042002

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePRAVASTATIN SODIUM USP

DMF 163092002

KYOWA HAKKO KOGYO CO LTDInactivePRAVASTATIN SODIUM

DMF 169752003

GUANGDONG NEW NORTH RIVER PHARMACEUTICAL CO LTDInactivePRAVASTATIN SODIUM

DMF 185802005

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactivePRAVASTATIN SODIUM (AMORPHOUS, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 187092005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 13, 2018

No patent or exclusivity listings for this strength.

#002 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2018

#003 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2018

#004 — 80MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2018