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FENTANYL CITRATE PRESERVATIVE FREE

ANDA

FENTANYL CITRATE | A210762 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FENTANYL CITRATE(TE code: AP)

API Supply Chain5 active DMFs7 inactive

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

VERANOVA LPFENTANYL CITRATE (BULK)

DMF 50381983

SPECGX LLCFENTANYL CITRATE (NEW PROCESS)

DMF 101281993

CAMBREX CHARLES CITY INCFENTANYL CITRATE USP

DMF 170552003

CURIA WISCONSIN INCFENTANYL CITRATE

DMF 181782005

CHATTEM CHEMICALS INCFENTANYL CITRATE USP

DMF 230132009

DIOSYNTH BVInactiveFENTANYL CITRATE

DMF 47511983

MALLINCKRODT CHEMICAL INCInactiveFENTANYL CITRATE USP

DMF 70511987

ABBOTT PHARMACEUTICALS INCInactiveFENTANYL CITRATE

DMF 82791989

JOHNSON MATTHEY INCInactiveFENTANYL CITRATE

DMF 85131990

BOEHRINGER INGELHEIM CHEMICALS INCInactiveFENTANYL CITRATE

DMF 178262004

NV ORGANONInactiveFENTANYL CITRATE

DMF 190812006

CAMBREX CHARLES CITY INCInactiveFENTANYL CITRATE USP MICRONIZED

DMF 197242006

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.05MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 3, 2019

No patent or exclusivity listings for this strength.