Orange Book product · Generic (ANDA)
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN; CODEINE PHOSPHATE
At a glance
Jun 27, 2019
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 27, 2019
7 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Strength
300MG;15MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 211610
Product number
001
Marketing status
RX
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
- 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
- 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.
