FDA Orange Book · active-ingredient family
Vancomycin hydrochloride
Vancomycin hydrochloride: 6 brands, 60 generics; first approved Jul 13, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 60 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
60
Listed patents
13
Next patent expiry
Mar 13, 2035
in 8 yr 7 mo
Brand (NDA) products
Originator applications
- VANCOMYCIN HYDROCHLORIDERLDRSZHEJIANG NOVUS PHARMNDA 21027420237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 1GM BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 5GM BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 10GM BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 750MG BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — EQ 1.5MG BASE/VIAL POWDER INTRAVENOUS, ORAL Rx — - HIKMANDA 21196220197 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 2GM BASE/400ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — - VANCOMYCIN HYDROCHLORIDERLDRSMYLAN LABS LTDNDA 20948120186 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/VIAL POWDER INTRAVENOUS Discontinued — EQ 750MG BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.5GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.75GM BASE/VIAL POWDER INTRAVENOUS Rx — EQ 2GM BASE/VIAL POWDER INTRAVENOUS Rx — - AZURITYNDA 20891020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE/ML FOR SOLUTION ORAL Rx AA EQ 50MG BASE/ML FOR SOLUTION ORAL Rx AA - BAXTER HLTHCARENDA 05067119995 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/100ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 750MG BASE/150ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1GM BASE/200ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) SOLUTION INTRAVENOUS Rx — - ANI PHARMSNDA 05060619862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Rx AB EQ 250MG BASE CAPSULE ORAL Rx AB
Generic (ANDA) products (60)
Abbreviated applications
- VANCOMYCIN HYDROCHLORIDEAUROBINDO PHARMAANDA 21813020262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE/ML FOR SOLUTION ORAL Rx AA EQ 50MG BASE/ML FOR SOLUTION ORAL Rx AA - VANCOMYCIN HYDROCHLORIDESTERISCIENCEANDA 21532420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.5GM BASE/VIAL POWDER INTRAVENOUS Rx AP - VANCOMYCIN HYDROCHLORIDEGLANDANDA 21814020253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.5GM BASE/VIAL POWDER INTRAVENOUS Rx AP - VANCOMYCIN HYDROCHLORIDEEUGIA PHARMAANDA 21740120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.5GM BASE/VIAL POWDER INTRAVENOUS Rx AP - VANCOMYCIN HYDROCHLORIDEHIKMAANDA 21748920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1.25GM BASE/VIAL POWDER INTRAVENOUS Rx AP EQ 1.5GM BASE/VIAL POWDER INTRAVENOUS Rx AP - VANCOMYCIN HYDROCHLORIDEAMNEALANDA 2153382023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SOLUTION ORAL Discontinued — - VANCOMYCIN HYDROCHLORIDEALKEM LABS LTDANDA 21491320222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE/ML FOR SOLUTION ORAL Rx AA EQ 50MG BASE/ML FOR SOLUTION ORAL Rx AA - VANCOMYCIN HYDROCHLORIDEMEITHEALANDA 2151952022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEMEITHEALANDA 21519720222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEMEITHEALANDA 21519620222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEASPIROANDA 21659120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEKNACKANDA 21305920223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 750MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEHAINAN POLYANDA 21582120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEHIKMAANDA 20330020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEHAINAN POLYANDA 21233220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEORIENT PHARMA CO LTDANDA 21072920192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Rx AB EQ 250MG BASE CAPSULE ORAL Rx AB - VANCOMYCIN HYDROCHLORIDEHIKMAANDA 20436020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEHIKMA PHARMSANDA 2066162018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEEUGIA PHARMAANDA 20578020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEEUGIA PHARMAANDA 20577920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEGLANDANDA 20569420164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDERSSAMSON MEDCLANDA 0915322016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100GM BASE POWDER INTRAVENOUS Rx — - VANCOMYCIN HYDROCHLORIDEHIKMAANDA 20410720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEXELLIA PHARMS APSANDA 20412520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDETEVA PHARMS USAANDA 20125120152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDETEVA PHARMS USAANDA 20125020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEXELLIA PHARMS APSANDA 20624320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEXELLIA PHARMS APSANDA 09137720152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDELUPINANDA 09043920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 250MG BASE CAPSULE ORAL Discontinued — - VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCESANDA 20227520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCESANDA 2022742013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCESANDA 2024642013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEPLANO PHARMSANDA 20104820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDESAGENT PHARMSANDA 20083720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEFRESENIUS KABI USAANDA 06545320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 250MG BASE CAPSULE ORAL Discontinued — - VANCOMYCIN HYDROCHLORIDEPAI HOLDINGSANDA 06547820122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Rx AB EQ 250MG BASE CAPSULE ORAL Rx AB - VANCOMYCIN HYDROCHLORIDESTRIDES PHARMAANDA 06549020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Rx AB EQ 250MG BASE CAPSULE ORAL Rx AB - VANCOMYCIN HYDROCHLORIDEWATSON LABSANDA 06551020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 125MG BASE CAPSULE ORAL Discontinued — EQ 250MG BASE CAPSULE ORAL Discontinued — - VANCOMYCIN HYDROCHLORIDERSMYLAN LABS LTDANDA 0915542011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 0914692011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEPLANO PHARMSANDA 09025020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEHOSPIRA INCANDA 0654552009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 06539720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 0654322008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEEUROFARMAANDA 06540120082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - LEDERLEANDA 06332119932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE/5ML FOR SOLUTION ORAL Discontinued — EQ 500MG BASE/6ML FOR SOLUTION ORAL Discontinued — - VANCOMYCIN HYDROCHLORIDERSHOSPIRAANDA 06293319922 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 750MG BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDERSHOSPIRAANDA 0629311992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDERSHOSPIRAANDA 06307619902 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDERSHOSPIRAANDA 06291219883 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 750MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1.5GM BASE/VIAL INJECTABLE INJECTION Rx — - VANCOMYCIN HYDROCHLORIDERSHOSPIRAANDA 0629111988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - VANCOMYCIN HYDROCHLORIDEHIKMAANDA 06287919882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - PHARMACIA AND UPJOHNANDA 06295619882 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - HIKMAANDA 06268219885 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 5GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - STERISCIENCEANDA 06281219873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 10GM BASE/VIAL INJECTABLE INJECTION Discontinued — - VANCOMYCIN HYDROCHLORIDERSFRESENIUS KABI USAANDA 06266319875 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 5GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 10GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 750MG BASE/VIAL INJECTABLE INJECTION Rx AP - STERISCIENCEANDA 06271619872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - STERISCIENCEANDA 06018019862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - STERISCIENCEANDA 06247619862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued — - ANI PHARMSANDA 06166719832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/6ML FOR SOLUTION ORAL Discontinued — EQ 250MG BASE/5ML FOR SOLUTION ORAL Rx —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10959947 | in 8 yr 7 mo | ProductU-3105 | |
| 10959948 | in 8 yr 7 mo | ProductU-3105 | |
| 10959949 | in 8 yr 7 mo | ProductU-3104 | |
| 10688046 | in 8 yr 7 mo | Product | |
| 10959946 | in 8 yr 7 mo | Product | |
| 10493028 | in 8 yr 7 mo | Product | |
| 11638692 | in 8 yr 7 mo | Product | |
| 11517609 | in 9 yr 3 mo | U-282 | |
| 10039804 | in 9 yr 3 mo | ProductU-282 | |
| 10188697 | in 9 yr 3 mo | ProductU-282 | |
| 10849956 | in 9 yr 3 mo | Product | |
| 12161690 | in 9 yr 3 mo | Product | |
| 11628200 | in 9 yr 3 mo | Product |
Approval history
FDA approval span
First approval
43 yr 10 mo ago
Most recent approval
1 mo ago
Approvals span 1983–2026 across 66 FDA applications.
Brand (NDA) 69%
Generic (ANDA) 6091%
Vancomycin hydrochloride: 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.
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- 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.
