Amiodarone Hydrochloride

Registrants1

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

Rubicon Research Private Limited

DUNS Number

918629544

Manufacturing Establishments1

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

Rubicon Research Private Limited

Labeler

Advagen Pharma Limited

Registrant

Rubicon Research Private Limited

DUNS Number

677604197

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

72888-039

Application Number

ANDA078578

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 14, 2021

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

AmiodaroneActive

Code: 976728SY6ZClass: ACTIBQuantity: 200 mg in 1 1