Orange Book product · Generic (ANDA)
PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE
At a glance
Nov 02, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 02, 2022
3 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
PROMETHAZINE HYDROCHLORIDE
Strength
12.5MG
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
AB
Application
ANDA 216446
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROMETHAZINE HYDROCHLORIDE
- 1984PROMETHAZINE HYDROCHLORIDE PLAINBrand (NDA)
NDA 008381 · ANI PHARMS
- —PHENERGANBrand (NDA)
NDA 008857 · WYETH AYERST
- —PHENERGANBrand (NDA)
NDA 010926 · PHARMOBEDIENT
- —PHENERGANBrand (NDA)
NDA 011689 · PHARMOBEDIENT
- —PHENERGANBrand (NDA)
NDA 007935 · DELCOR ASSET CORP
- 2021PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213890 · QUAGEN
- 2012PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091675 · COSETTE PHARMS NC
- 2009PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040882 · AMNEAL PHARMS
- 2009PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040891 · STRIDES PHARMA
- 2008PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040785 · WOCKHARDT BIO AG
- 2008PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040737 · XGEN PHARMS
- 2007PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040718 · SUN PHARMA CANADA
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.
