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NIZORAL ANTI-DANDRUFF

NDA

KETOCONAZOLE | N020310 | KRAMER LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs8 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

JANSSEN PHARMACEUTICA NVKETOCONAZOLE DRUG SUBSTANCE

DMF 100371993

QUIMICA SINTETICA SAKETOCONAZOLE

DMF 120231996

DERIVADOS QUIMICOS SAUKETOCONAZOLE

DMF 147942001

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)KETOCONAZOLE

DMF 162122002

PIRAMAL PHARMA LTDKETOCONAZOLE

DMF 172902004

SHARON BIO MEDICINE LTDKETOCONAZOLE USP

DMF 250132011

SS PHARMA LLCKETOCONAZOLE USP

DMF 384172023

QUIMICA SINTETICA SAInactiveKETOCONAZOLE

DMF 97181992

ESTEVE QUIMICA SAInactiveKETOCONAZOLE

DMF 115791995

ALBEMARLE CORPInactiveKETOCONAZOLE

DMF 121711996

QUIMICA FINA FARMEX SA DE CVInactiveKETOCONAZOLE

DMF 127941997

NAPP TECHNOLOGIES INCInactiveKETOCONAZOLE USP

DMF 149482000

RECORDATI ESPANA SLInactiveKETOCONAZOLE

DMF 159602002

FDC LTDInactiveKETOCONAZOLE

DMF 168022003

GUFIC BIOSCIENCES LTDInactiveKETOCONAZOLE USP

DMF 169152003

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
May 4, 2026	SUPPL -42	View Letter (PDF)
Nov 19, 2025	SUPPL -41	View Letter (PDF)
Feb 6, 2025	SUPPL -34	View Letter (PDF)
Jul 8, 2024	SUPPL -33	View Letter (PDF)
Mar 15, 2024	SUPPL -32	View Letter (PDF)
Oct 3, 2023	SUPPL -31	View Letter (PDF)
Jan 20, 2023	SUPPL -29	View Letter (PDF)
May 16, 2022	SUPPL -27	View Letter (PDF)
Feb 3, 2021	SUPPL -26	View Letter (PDF)
Apr 21, 2020	SUPPL -24	View Letter (PDF)
Nov 27, 2019	SUPPL -23	View Letter (PDF)
Sep 21, 2010	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

SHAMPOO;TOPICAL | Approved: Oct 10, 1997

No patent or exclusivity listings for this strength.