Griseofulviin (microsize)

Registrants1

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

PSS World Medical, Inc.

DUNS Number

101822862

Manufacturing Establishments6

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

STAT RX USA LLC

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

786036330

Keltman Pharmaceuticals, Inc.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

362861077

PSS World Medical, Inc.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

791528623

Dispensing Solutions, Inc.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

066070785

SCRIPT PAK

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

964420108

Rebel Distirbutors Corp.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

118802834

Products1

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

Product Details

NDC Product Code

42254-306

Application Number

ANDA065394

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

July 27, 2010

Ingredients

DOCUSATE SODIUMInactive

Code: F05Q2T2JA0Class: IACT

GriseofulvinActive

Code: 32HRV3E3D5Class: ACTIBQuantity: 125 mg in 5 mL

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

MAGNESIUM ALUMINUM SILICATEInactive

Code: 6M3P64V0NCClass: IACT

MENTHOLInactive

Code: L7T10EIP3AClass: IACT

SODIUM ALGINATEInactive

Code: C269C4G2ZQClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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Griseofulviin (microsize)

FDA Approval Summary

Registrants1

Manufacturing Establishments6

Keltman Pharmaceuticals, Inc.

Products1

Griseofulviin (microsize)

Product Details