| Form
| Dosage
| Status
| Therapeutic Equivalence
| Active Ingred
| Ref.
| Sponsor
| Document
|
| CAPSULE; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| TEVA
| 088324
|
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| CLONMEL
| 040098
2003-12-23 Review
2003-12-23 Letter
2003-12-23 Label |
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| HI TECH PHARMA
| 040119
|
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ACTAVIS MID ATLANTIC
| 085861
|
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MORTON GROVE
| 087006
|
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| PHARM ASSOC
| 087508
|
| SOLUTION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MIKART
| 089450
|
| SUSPENSION; ORAL
| 120MG/5ML;12MG/5ML
| Prescription
| AA (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| VALEANT
| 086024
|
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| 040223
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| " |
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| " |
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MALLINCKRODT
| 040419
2001-05-31 Letter |
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MALLINCKRODT
| " |
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MALLINCKRODT
| " |
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ANDRX PHARMS
| 040443
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ANDRX PHARMS
| " |
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ANDRX PHARMS
| " |
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ABLE
| 040452
2003-04-09 Letter |
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ABLE
| 040459
2003-04-09 Letter |
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 081249
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 081250
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| WARNER CHILCOTT
| 085218
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| KV PHARM
| 085288
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 085291
|
| TABLET; ORAL
| 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| KV PHARM
| 085363
|
| TABLET; ORAL
| 325MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| KV PHARM
| 085364
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| KV PHARM
| 085365
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MUTUAL PHARM
| 085794
|
| TABLET; ORAL
| 300MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MUTUAL PHARM
| 085795
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 085917
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 085964
|
| TABLET; ORAL
| 300MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| WARNER CHILCOTT
| 085992
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| HALSEY
| 086549
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| PUREPAC PHARM
| 086681
2003-07-30 Review |
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| PUREPAC PHARM
| 086683
2003-07-30 Review |
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| RANBAXY
| 087083
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 087423
|
| TABLET; ORAL
| 300MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| SANDOZ
| 087433
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| PHARMERAL
| 087762
|
| TABLET; ORAL
| 300MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| 088353
|
| TABLET; ORAL
| 300MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| 088354
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| DURAMED PHARMS BARR
| 088355
|
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| TEVA
| 088627
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| TEVA
| 088628
|
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| TEVA
| 088629
|
| TABLET; ORAL
| 650MG;30MG
| Prescription
| (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MIKART
| 089231
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MIKART
| 089238
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MIKART
| 089244
|
| TABLET; ORAL
| 650MG;60MG
| Prescription
| (Reference Drug)
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MIKART
| 089363
|
| TABLET; ORAL
| 500MG;15MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ROXANE
| 089511
|
| TABLET; ORAL
| 500MG;30MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ROXANE
| 089512
|
| TABLET; ORAL
| 500MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| ROXANE
| 089513
|
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MUTUAL PHARM
| 089671
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MUTUAL PHARM
| 089672
|
| TABLET; ORAL
| 300MG;60MG
| Discontinued
|
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| MUTUAL PHARM
| 089673
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| VINTAGE PHARMS
| 089805
|
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| VINTAGE PHARMS
| 089828
|
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| VINTAGE
| 089990
|
| TABLET; ORAL
| 300MG;15MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| WATSON LABS
| 089997
|
| TABLET; ORAL
| 300MG;30MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| WATSON LABS
| 089998
|
| TABLET; ORAL
| 300MG;60MG
| Prescription
| AA
| ACETAMINOPHEN; CODEINE PHOSPHATE
| Acetaminophen
| WATSON LABS
| 089999
|
| Role code
| Indications
| Reaction
| # Reports
|
| PS
| ARTHRALGIA
| COMPLETED SUICIDE
| 1
|
| PS
| ARTHRALGIA
| GASTROINTESTINAL HAEMORRHAGE
| 1
|
| PS
| ARTHRALGIA
| HEPATIC FAILURE
| 1
|
| PS
| ARTHRALGIA
| INTENTIONAL OVERDOSE
| 1
|
| PS
| ARTHRALGIA
| RENAL FAILURE
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| ALANINE AMINOTRANSFERASE INCREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| ANOXIC ENCEPHALOPATHY
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| ASPARTATE AMINOTRANSFERASE INCREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| BLOOD AMYLASE INCREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| BLOOD GLUCOSE DECREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| BLOOD POTASSIUM INCREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| BRAIN DEATH
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| CARDIAC ARREST
| 3
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| COAGULOPATHY
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| COMPLETED SUICIDE
| 7
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| DRUG TOXICITY
| 2
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| ENCEPHALOPATHY
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| HEART RATE DECREASED
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| HEPATIC FAILURE
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| HYPOTENSION
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| LACTIC ACIDOSIS
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| LOSS OF CONSCIOUSNESS
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| MULTIPLE DRUG OVERDOSE INTENTIONAL
| 7
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| PNEUMONIA
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| PNEUMONIA ASPIRATION
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| PULMONARY CONGESTION
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| PULMONARY OEDEMA
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| RENAL FAILURE
| 1
|
| PS
| DRUG USE FOR UNKNOWN INDICATION
| VOMITING
| 1
|
| SS
| ARTHRALGIA
| ASPARTATE AMINOTRANSFERASE INCREASED
| 1
|
| SS
| ARTHRALGIA
| MULTIPLE DRUG OVERDOSE ACCIDENTAL
| 1
|
| SS
| ARTHRALGIA
| RESPIRATORY FAILURE
| 1
|
| SS
| PAIN
| ACCIDENTAL OVERDOSE
| 1
|
| SS
| PAIN
| BRAIN DEATH
| 1
|
| SS
| PAIN
| GASTROINTESTINAL HAEMORRHAGE
| 1
|
| SS
| PAIN
| HEPATIC FAILURE
| 1
|
| SS
| PAIN
| INTERNATIONAL NORMALISED RATIO INCREASED
| 1
|
| SS
| PAIN
| LOSS OF CONSCIOUSNESS
| 1
|
| SS
| PAIN
| PUPIL FIXED
| 1
|
| SS
| PAIN
| RENAL FAILURE
| 1
|
| C
| PAIN
| BLOOD CREATINE PHOSPHOKINASE INCREASED
| 1
|
| C
| PAIN
| CARDIAC ARREST
| 1
|
| C
| PAIN
| COAGULOPATHY
| 1
|
| C
| PAIN
| METABOLIC ACIDOSIS
| 1
|
| C
| PAIN
| RENAL IMPAIRMENT
| 1
|
| C
| PAIN
| RESPIRATORY FAILURE
| 1
|
| C
| PAIN
| RHABDOMYOLYSIS
| 1
|