Orange Book product · Brand (NDA)
LOZOL
INDAPAMIDE
At a glance
Apr 29, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 1993
33 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
INDAPAMIDE
Strength
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018538
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.
- 1998INDAPAMIDEGeneric (ANDA)
ANDA 075201 · ANI PHARMS
- 1998INDAPAMIDEGeneric (ANDA)
ANDA 075105 · AUROBINDO PHARMA USA
- 1998INDAPAMIDEGeneric (ANDA)
ANDA 074498 · ANI PHARMS
- 1997INDAPAMIDEGeneric (ANDA)
ANDA 074665 · TEVA
- 1997INDAPAMIDEGeneric (ANDA)
ANDA 074461 · RISING
- 1996INDAPAMIDEGeneric (ANDA)
ANDA 074585 · WATSON LABS
- 1996INDAPAMIDEGeneric (ANDA)
ANDA 074722 · ACTAVIS ELIZABETH
- 1996INDAPAMIDEGeneric (ANDA)
ANDA 074594 · CHARTWELL RX
- 1996INDAPAMIDEGeneric (ANDA)
ANDA 074299 · ANI PHARMS
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.
