FDA Orange Book · active-ingredient family
Indapamide
Indapamide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOZOL · NDA 018538
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOZOLRLD×2 | SANOFI AVENTIS US | NDA 018538 | — | Apr 29, 1993 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INDAPAMIDE×2 | ANI PHARMS | ANDA 075201 | — | Dec 04, 1998 | |
| INDAPAMIDE×2 | AUROBINDO PHARMA USA | ANDA 075105 | — | Jul 23, 1998 | |
| INDAPAMIDE×2 | ANI PHARMS | ANDA 074498 | — | Feb 12, 1998 | |
| INDAPAMIDE×2 | TEVA | ANDA 074665 | — | Apr 04, 1997 | |
| INDAPAMIDE×2 | RISING | ANDA 074461 | AB | Mar 26, 1997 | |
| INDAPAMIDE×2 | WATSON LABS | ANDA 074585 | — | Sep 26, 1996 | |
| INDAPAMIDE×2 | ACTAVIS ELIZABETH | ANDA 074722 | AB | Jun 17, 1996 | |
| INDAPAMIDE×2 | CHARTWELL RX | ANDA 074594 | — | May 23, 1996 | |
| INDAPAMIDE×2 | ANI PHARMS | ANDA 074299 | AB | Apr 29, 1996 |
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.
Indapamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
