Orange Book product · Generic (ANDA)
PROMETHEGAN
PROMETHAZINE HYDROCHLORIDE
At a glance
Aug 14, 1987
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 14, 1987
39 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PROMETHAZINE HYDROCHLORIDE
Strength
50MG
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
Not listed
Application
ANDA 087165
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 2022PROMETHAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216446 · ANNORA PHARMA
- 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
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.
