FDA Orange Book · active-ingredient family
Pravastatin sodium
Pravastatin sodium is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRAVACHOL · NDA 019898
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRAVACHOLRLD×4 | BRISTOL MYERS SQUIBB | NDA 019898 | — | Oct 31, 1991 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRAVASTATIN SODIUM×3 | HISUN PHARM HANGZHOU | ANDA 206061 | — | Nov 23, 2018 | |
| PRAVASTATIN SODIUM×4 | BIOCON PHARMA | ANDA 209869 | AB | Apr 13, 2018 | |
| PRAVASTATIN SODIUM×4 | AUROBINDO PHARMA | ANDA 203367 | AB | Feb 02, 2017 | |
| PRAVASTATIN SODIUM×4 | ACCORD HLTHCARE | ANDA 207068 | AB | Nov 17, 2016 | |
| PRAVASTATIN SODIUM×4 | PHARMOBEDIENT | ANDA 079187 | — | May 27, 2010 | |
| PRAVASTATIN SODIUM×4 | ZYDUS PHARMS USA | ANDA 077751 | — | Apr 30, 2008 | |
| PRAVASTATIN SODIUM | AUROBINDO PHARMA USA | ANDA 077793 | AB | Jan 15, 2008 | |
| PRAVASTATIN SODIUM×4 | CHARTWELL RX | ANDA 077917 | AB | Jan 08, 2008 | |
| PRAVASTATIN SODIUM×4 | GLENMARK PHARMS LTD | ANDA 077987 | AB | May 11, 2007 | |
| PRAVASTATIN SODIUM×4 | RANBAXY LABS LTD | ANDA 076445 | — | Apr 23, 2007 | |
| PRAVASTATIN SODIUM×4 | PLIVA HRVATSKA DOO | ANDA 077730 | — | Nov 21, 2006 | |
| PRAVASTATIN SODIUM×4 | APOTEX | ANDA 076341 | AB | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×4 | CIPLA | ANDA 077904 | AB | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×4 | DR REDDYS LABS INC | ANDA 076714 | AB | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×4 | PHARMOBEDIENT | ANDA 077013 | — | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×4 | SENORES PHARMS | ANDA 077491 | AB | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×4 | WATSON LABS | ANDA 076939 | AB | Oct 23, 2006 | |
| PRAVASTATIN SODIUM×3 | AUROBINDO PHARMA USA | ANDA 076056 | AB | Apr 24, 2006 |
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.
Pravastatin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
