Orange Book product · Brand (NDA)
PHENERGAN
PROMETHAZINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PROMETHAZINE HYDROCHLORIDE
Strength
12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUPPOSITORY
Route
RECTAL
TE code
Not listed
Application
NDA 010926
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1984PROMETHAZINE HYDROCHLORIDE PLAINBrand (NDA)
NDA 008381 · ANI PHARMS
- —PHENERGANBrand (NDA)
NDA 008857 · WYETH AYERST
- —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
- 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.
