FDA Orange Book · active-ingredient family
Pravastatin sodium
Pravastatin sodium: 1 brand, 18 generics; first approved Oct 31, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
18
Listed patents
0
Presentations
73
Brand (NDA) products
Originator applications
- PRAVACHOLRLDBRISTOL MYERS SQUIBBNDA 01989819914 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued —
Generic (ANDA) products (18)
Abbreviated applications
- PRAVASTATIN SODIUMHISUN PHARM HANGZHOUANDA 20606120183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - PRAVASTATIN SODIUMBIOCON PHARMAANDA 20986920184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMAUROBINDO PHARMAANDA 20336720174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMACCORD HLTHCAREANDA 20706820164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMPHARMOBEDIENTANDA 07918720104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - PRAVASTATIN SODIUMZYDUS PHARMS USAANDA 07775120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMRSAUROBINDO PHARMA USAANDA 0777932008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMCHARTWELL RXANDA 07791720084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMGLENMARK PHARMS LTDANDA 07798720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMRANBAXY LABS LTDANDA 07644520074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - PRAVASTATIN SODIUMPLIVA HRVATSKA DOOANDA 07773020064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 30MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - PRAVASTATIN SODIUMAPOTEXANDA 07634120064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMCIPLAANDA 07790420064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMDR REDDYS LABS INCANDA 07671420064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMPHARMOBEDIENTANDA 07701320064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - PRAVASTATIN SODIUMSENORES PHARMSANDA 07749120066 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 30MG TABLET ORAL Rx — 60MG TABLET ORAL Rx — - PRAVASTATIN SODIUMWATSON LABSANDA 07693920064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - PRAVASTATIN SODIUMAUROBINDO PHARMA USAANDA 07605620063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
35 yr 5 mo ago
Most recent approval
1 mo ago
Approvals span 1991–2026 across 19 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1895%
Pravastatin sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
