Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Atlantic Biologicals Corps
047437707
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Atlantic Biologicals Corps
Atlantic Biologicals Corps
Atlantic Biologicals Corps
047437707
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Polistirex and Chlorpheniramine Polisitrex
Product Details
NDC Product Code
17856-0235Application Number
ANDA091632Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 17, 2014HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 5 mL
ChlorpheniramineActive
Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 8 mg in 5 mL
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679ZClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
VINYL ACETATEInactive
Code: L9MK238N77Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6SClass: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6TClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT