Orange Book product · Brand (NDA)
RIFADIN
RIFAMPIN
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
RIFAMPIN
Strength
150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 050420
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.
- 1989RIFADINBrand (NDA)
NDA 050627 · SANOFI AVENTIS US
- —RIMACTANEBrand (NDA)
NDA 050429 · OXFORD PHARMS
- 2016RIFAMPINGeneric (ANDA)
ANDA 205039 · HIKMA PHARMS
- 2016RIFAMPINGeneric (ANDA)
ANDA 206736 · WATSON PHARMS TEVA
- 2014RIFAMPINGeneric (ANDA)
ANDA 091181 · FRESENIUS KABI USA
- 2014RIFAMPINGeneric (ANDA)
ANDA 204101 · AVET LIFESCIENCES
- 2013RIFAMPINGeneric (ANDA)
ANDA 090034 · LUPIN PHARMS
- 2010RIFAMPINGeneric (ANDA)
ANDA 065502 · EPIC PHARMA LLC
- 2008RIFAMPINGeneric (ANDA)
ANDA 065421 · MYLAN LABS LTD
- 2008RIFAMPINGeneric (ANDA)
ANDA 065390 · CHARTWELL MOLECULAR
- 2001RIFAMPINGeneric (ANDA)
ANDA 065028 · HIKMA
- 1999RIFAMPINGeneric (ANDA)
ANDA 064217 · HIKMA
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.
