Orange Book product · Brand (NDA)
NYDRAZID
ISONIAZID
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
ISONIAZID
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 008392
Product number
003
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.
- —NYDRAZIDBrand (NDA)
NDA 008662 · SANDOZ
- —RIMIFONBrand (NDA)
NDA 008420 · ROCHE
- —ISONIAZIDBrand (NDA)
NDA 008678 · EPIC PHARMA LLC
- —ISONIAZIDBrand (NDA)
NDA 008499 · LILLY
- —ISONIAZIDBrand (NDA)
NDA 008428 · PANRAY
- 2014ISONIAZIDGeneric (ANDA)
ANDA 202610 · THEPHARMANETWORK LLC
- 2005ISONIAZIDGeneric (ANDA)
ANDA 040648 · SANDOZ
- 1997ISONIAZIDGeneric (ANDA)
ANDA 081118 · CHARTWELL RX
- 1997ISONIAZIDGeneric (ANDA)
ANDA 040090 · OMNIVIUM PHARMS
- 1988LANIAZIDGeneric (ANDA)
ANDA 089776 · CHARTWELL MOLECULAR
- 1986LANIAZIDGeneric (ANDA)
ANDA 089243 · LANNETT
- 1983ISONIAZIDGeneric (ANDA)
ANDA 088235 · CMP PHARMA INC
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.
