FDA Orange Book · active-ingredient family
Pregabalin
Pregabalin: 3 brands, 52 generics; first approved Dec 30, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 52 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
52
Listed patents
6
Next patent expiry
Nov 02, 2026
in 3 mo
Brand (NDA) products
Originator applications
- LYRICA CRRLDUPJOHNNDA 20950120173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 165MG TABLET, EXTENDED RELEASE ORAL Rx AB 330MG TABLET, EXTENDED RELEASE ORAL Rx AB - UPJOHNNDA 0224882010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML SOLUTION ORAL Rx AA - LYRICARLDUPJOHNNDA 02144620048 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB
Generic (ANDA) products (52)
Abbreviated applications
- PREGABALINAIPING PHARM INCANDA 21785720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 330MG TABLET, EXTENDED RELEASE ORAL Rx AB 165MG TABLET, EXTENDED RELEASE ORAL Rx AB - PREGABALINUNICHEMANDA 21959320268 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINFOURRTS LABSANDA 21852920268 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINJUBILANT GENERICSANDA 20953020258 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINPHARMOBEDIENTANDA 09122220258 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINTORRENTANDA 20694220258 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINMACLEODS PHARMS LTDANDA 20592420248 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINCHANGZHOU PHARMANDA 21432220248 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB - PREGABALINREGCON HOLDINGSANDA 20811320248 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINSTRIDES PHARMAANDA 20988320248 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINCADILA PHARMS LTDANDA 20645220238 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINEPIC PHARMA LLCANDA 21449620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 165MG TABLET, EXTENDED RELEASE ORAL Rx AB 330MG TABLET, EXTENDED RELEASE ORAL Rx AB - PREGABALINSTRIDES PHARMAANDA 21575520238 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINAUROBINDO PHARMAANDA 20532120238 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINZYDUS PHARMSANDA 20675220228 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINSCIEGEN PHARMSANDA 21567520223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINPRINSTON INCANDA 20788320228 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINZYDUS PHARMSANDA 21557720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINADAPTISANDA 21619720228 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINLUPIN LTDANDA 09104020228 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINRUBICON RESEARCHANDA 21524920223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 165MG TABLET, EXTENDED RELEASE ORAL Rx AB 330MG TABLET, EXTENDED RELEASE ORAL Rx AB - PREGABALINESKAYEFANDA 21298820228 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINPATRINANDA 2126042022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML SOLUTION ORAL Rx AA - PREGABALINPHARMOBEDIENTANDA 2119672021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINAPOTEXANDA 21168520218 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINALVOGENANDA 21168720213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINPHARMOBEDIENTANDA 2114312021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINALVOGENANDA 21159320213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINAPOTEXANDA 21331320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINMSNANDA 21322620213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Rx AB 165MG TABLET, EXTENDED RELEASE ORAL Rx AB 330MG TABLET, EXTENDED RELEASE ORAL Rx AB - PREGABALINPHARMOBEDIENTANDA 2119482021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINSUN PHARMANDA 21188920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 82.5MG TABLET, EXTENDED RELEASE ORAL Discontinued — 165MG TABLET, EXTENDED RELEASE ORAL Discontinued — 330MG TABLET, EXTENDED RELEASE ORAL Discontinued — - PREGABALINACTAVIS ELIZABETHANDA 09102520208 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINCREEKWOOD PHARMSANDA 21342320208 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINCHARTWELL RXANDA 21286520204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB - PREGABALINCIPLAANDA 21228020208 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINRENATAANDA 21058520196 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINSUN PHARMANDA 09115720198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINHETERO LABS LTD IIIANDA 20691220198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINALKEM LABS LTDANDA 20779920198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB - PREGABALINYILINGANDA 21089120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINPHARMOBEDIENTANDA 09122820198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINALEMBICANDA 20345920198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINAMNEAL PHARMS COANDA 20974320198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINDR REDDYSANDA 20966420198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALININVAGEN PHARMSANDA 21138420198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINMSNANDA 20935720198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINRISINGANDA 21043220198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINSCIEGEN PHARMSANDA 20867720198 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB 75MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 150MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 225MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB - PREGABALINTEVA PHARMSANDA 09121920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Discontinued — 50MG CAPSULE ORAL Discontinued — - PREGABALINTEVA PHARMSANDA 09122420196 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 75MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 150MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 225MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — - PREGABALINALKEM LABS LTDANDA 2076232019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML SOLUTION ORAL Rx AA
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10022447 | in 3 mo | U-2137 | |
| 8945620 | in 3 mo | ProductU-2136 | |
| 9144559 | in 3 mo | Product | |
| 9144559*PED | in 9 mo | ||
| 10022447*PED | in 9 mo | ||
| 8945620*PED | in 9 mo |
Approval history
FDA approval span
First approval
21 yr 11 mo ago
Most recent approval
1 mo ago
Approvals span 2004–2026 across 55 FDA applications.
Brand (NDA) 35%
Generic (ANDA) 5295%
Pregabalin: 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.
