Methyldopa

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.

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

Keltman Pharmaceuticals, Inc.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

362861077

Rebel Distirbutors Corp.

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

118802834

STAT RX USA LLC

Labeler

Rebel Distributors Corp

Registrant

PSS World Medical, Inc.

DUNS Number

786036330

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

42254-351

Application Number

ANDA070098

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

August 3, 2007

Ingredients

MethyldopaActive

Code: 56LH93261YClass: ACTIMQuantity: 250 mg in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOLSInactive

Code: 3WJQ0SDW1AClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHYLCELLULOSE (400 MPA.S)Inactive

Code: O0GN6F9B2YClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

CALCIUM SULFATEInactive

Code: WAT0DDB505Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE H)Inactive

Code: RFW2ET671PClass: IACT

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Methyldopa

FDA Approval Summary

Registrants1

Manufacturing Establishments6

Keltman Pharmaceuticals, Inc.

Products1

Methyldopa

Product Details