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FLUOCINOLONE ACETONIDE

ANDA

FLUOCINOLONE ACETONIDE | A201759 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Arent Fox LLP FDA-2018-P-0269 · 3 docket documents Arent Fox LLP filed this petition on behalf of Identi Pharmaceuticals Inc. requesting that the FDA amend the Orange Book to designate ANDA No. A201759 for Fluocinolone Acetonide 0.01% Topical Oil (Scalp oil) as the Reference Standard drug, replacing the current reference listed drug NDA No. N019452	505(q)	2018-01-24	Denied	Arent Fox LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain4 active DMFs7 inactive

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

TAPI NL BVFLUOCINOLONE ACETONIDE (PROCESS I)

DMF 44861982

FARMABIOS SPAFLUOCINOLONE ACETONIDE

DMF 173952004

TAPI NL BVFLUOCINOLONE ACETONIDE - PROCESS II

DMF 238752010

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOCINOLONE ACETONIDE

DMF 404062024

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE

DMF 4181961

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE ACETATE

DMF 8061964

ANTIBIOTICOS SPAInactiveFLUOCINOLONE ACETONIDE

DMF 27871976

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINOLONE ACETONIDE

DMF 29441977

QUATRUMInactiveFLUOCINOLONE ACETONIDE

DMF 73861988

FARMABOISInactiveFLUOCINOLONE ACETONIDE

DMF 74581988

SICOR SPAInactiveFLUOCINOLONE ACETONIDE 1,2-DIHYDRO

DMF 155722001

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

Products (1)

#001 — 0.01%

0 patents0 exclusivities▴

OIL;TOPICAL | Approved: Oct 17, 2011

No patent or exclusivity listings for this strength.