Orange Book product · Generic (ANDA)
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN; CODEINE PHOSPHATE
At a glance
Nov 10, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 10, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Strength
120MG/5ML;12MG/5ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 091238
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; CODEINE PHOSPHATE
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ANDA 212418 · ELITE LABS INC
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ANDA 211610 · HIBROW HLTHCARE
- 2013ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 202800 · AUROLIFE PHARMA LLC
- 2008ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040779 · AMNEAL PHARMS NY
- 2002ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040452 · ABLE
- 2002ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040459 · ABLE
- 1997ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040223 · DURAMED PHARMS BARR
- 1996ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040098 · DAVA PHARMS INC
- 1996ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 040119 · PAI HOLDINGS
- 1994ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 089997 · CHARTWELL
- 1994ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 089998 · CHARTWELL
- 1994ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 089999 · CHARTWELL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
