promethazine hydrochloride and codeine phosphate

Registrants (1)

Nostrum Laboratories, Inc.

DUNS Number

791055549

Manufacturing Establishments (1)

Nostrum Laboratories, Inc.

Labeler

Nostrum Laboratories, Inc.

Registrant

Nostrum Laboratories, Inc.

DUNS Number

791055549

Products (1)

NDC Product Code

70408-185

Application Number

ANDA090180

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 11, 2018

Ingredients

CodeineActive

Code: GSL05Y1MN6Class: ACTIBQuantity: 10 mg in 5 mL

PromethazineActive

Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

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promethazine hydrochloride and codeine phosphate

Registrants (1)

Manufacturing Establishments (1)

Products (1)

promethazine hydrochloride and codeine phosphate