Hydrocodone Polistirex and Chlorpheniramine Polistirex

Manufacturing Establishments (1)

ATLANTIC BIOLOGICALS CORP.

Labeler

ATLANTIC BIOLOGICALS CORP.

DUNS Number

047437707

Products (1)

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release

NDC Product Code

17856-0087

Application Number

ANDA091632

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 10, 2023

Ingredients

ChlorpheniramineActive

Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 8 mg in 5 mL

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 5 mL

ASCORBIC ACIDInactive

Code: PQ6CK8PD0RClass: IACT

POLYVINYL ACETATEInactive

Code: 32K497ZK2UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

HIGH FRUCTOSE CORN SYRUPInactive

Code: XY6UN3QB6SClass: IACT

METHYLPARABENInactive

Code: A2I8C7HI9TClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OHClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM ASCORBATEInactive

Code: S033EH8359Class: IACT

SODIUM METABISULFITEInactive

Code: 4VON5FNS3CClass: IACT

SODIUM POLYSTYRENE SULFONATEInactive

Code: 1699G8679ZClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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Manufacturing Establishments (1)

Products (1)

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release