Orange Book product · Brand (NDA)
DIDREX
BENZPHETAMINE 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
BENZPHETAMINE HYDROCHLORIDE
Strength
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
NDA 012427
Product number
003
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.
- 2015BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090346 · EPIC PHARMA LLC
- 2015BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040747 · TEDOR PHARM
- 2012BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202061 · AVET LIFESCIENCES
- 2010BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090473 · CHARTWELL
- 2010BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090968 · KVK TECH
- 2008BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040845 · IMPAX LABS
- 2007BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040714 · EPIC PHARMA LLC
- 2007BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040773 · SPECGX LLC
- 2006BENZPHETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040578 · SCINOPHARM TAIWAN
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.
