VERELAN PM

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Societal CDMO Gainesville, LLC

DUNS Number

057585150

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Societal CDMO Gainesville, LLC

Labeler

Lannett Company, Inc.

Registrant

Societal CDMO Gainesville, LLC

DUNS Number

057585150

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

62175-571

Application Number

NDA020943

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 1, 2022

Ingredients

VerapamilActive

Code: V3888OEY5RClass: ACTIBQuantity: 200 mg in 1 1

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

VERELAN PM

Product Details

NDC Product Code

62175-572

Application Number

NDA020943

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 1, 2022

Ingredients

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

VerapamilActive

Code: V3888OEY5RClass: ACTIBQuantity: 300 mg in 1 1

FUMARIC ACIDInactive

Code: 88XHZ13131Class: IACT

VERELAN PM

Product Details

NDC Product Code

62175-570

Application Number

NDA020943

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

July 1, 2022

Ingredients

VerapamilActive

Code: V3888OEY5RClass: ACTIBQuantity: 100 mg in 1 1

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FUMARIC ACIDInactive

Code: 88XHZ13131Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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FDA Approval Summary

Registrants1

Manufacturing Establishments1

Products3

VERELAN PM

Product Details

VERELAN PM

Product Details

VERELAN PM

Product Details