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Active ingredient

Posaconazole

37 finished FDA listings contain Posaconazole as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
POSACONAZOLE
Dosage forms
Injection, Injection, Solution, Powder, For Suspension, Solution, Suspension, Tablet, Tablet, Coated, Tablet, Delayed Release
Routes
Intravenous, Oral
Manufacturers / labelers
29
Strengths listed
100 mg/1 · 18 mg/ml · 300 mg/1 · 40 mg/ml
Brand names in FDA listings
Noxafil, Posaconazole

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 282446

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 022003SCHERING2006-09-152
NDA 205053MERCK SHARP DOHME2013-11-252
NDA 205596MERCK SHARP DOHME2014-03-131
ANDA 212411SINOTHERAPEUTICS INC2019-08-214
ANDA 208773HIKMA2020-05-151
ANDA 213454AET PHARMA2021-02-012
NDA 214770MSD MERCK CO2021-05-311
ANDA 214476BIOCON PHARMA2022-02-041
ANDA 212500DR REDDYS2022-04-072
ANDA 212226SPECGX LLC2022-05-102
ANDA 208768PH HEALTH2022-05-251
ANDA 214321HETERO LABS LTD III2022-12-082
ANDA 216626AMNEAL2022-12-222
ANDA 216488PHARMAZONE2023-08-285
ANDA 211500MYLAN LABS LTD2023-12-261
ANDA 209983FRESENIUS KABI USA2023-12-261
ANDA 214842EUGIA PHARMA2023-12-261
ANDA 217553GLAND2023-12-263
ANDA 217119AUROBINDO PHARMA2024-07-181
ANDA 219057ASPIRO2024-12-231
ANDA 218434MSN2025-02-241

Official labeling on DailyMed

Showing the 12 most recent of 33 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.