Orange Book product · Generic (ANDA)
TYLENOL W/ CODEINE
ACETAMINOPHEN; CODEINE PHOSPHATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Strength
325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 085056
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
- 2019ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 212418 · ELITE LABS INC
- 2019ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 211610 · HIBROW HLTHCARE
- 2013ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 202800 · AUROLIFE PHARMA LLC
- 2011ACETAMINOPHEN AND CODEINE PHOSPHATEGeneric (ANDA)
ANDA 091238 · CHARTWELL MOLECULAR
- 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
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.
