Orange Book product · Brand (NDA)
RIFADIN
RIFAMPIN
At a glance
May 25, 1989
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 1989
37 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
RIFAMPIN
Strength
600MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050627
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- —RIFADINBrand (NDA)
NDA 050420 · 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.
