Orange Book product · Brand (NDA)
FASTIN
PHENTERMINE 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
PHENTERMINE HYDROCHLORIDE
Strength
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017352
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2016PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204318 · AUROLIFE PHARMA LLC
- 2014PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205019 · NUVO PHARM
- 2014PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 205017 · NUVO PHARM
- 2014PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204414 · INVAGEN PHARMS
- 2014PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202858 · INVAGEN PHARMS
- 2014PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202846 · INVAGEN PHARMS
- 2012PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202248 · ELITE LABS
- 2012PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087022 · LANNETT
- 2011PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201961 · LANNETT CO INC
- 2010PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091359 · LANNETT CO INC
- 2010PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090591 · BARR
- 2008PHENTERMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040887 · KVK TECH
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.
