Ultramicrosize Griseofulvin

Registrants1

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

Sigmapharm Laboratories, LLC

DUNS Number

556234636

Manufacturing Establishments1

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

Sigmapharm Laboratories, LLC

Labeler

Sigmapharm Laboratories, LLC

Registrant

Sigmapharm Laboratories, LLC

DUNS Number

556234636

Products2

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

Product Details

NDC Product Code

42794-013

Application Number

ANDA202545

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 14, 2022

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

POLOXAMER 188Inactive

Code: LQA7B6G8JGClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GriseofulvinActive

Code: 32HRV3E3D5Class: ACTIBQuantity: 125 mg in 1 1

POVIDONEInactive

Code: FZ989GH94EClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT