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SODIUM ACETATE

ANDA

SODIUM ACETATE | A214805 | MILLA PHARMACEUTICALS INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SODIUM ACETATE(TE code: AP)

API Supply Chain7 active DMFs4 inactive

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

MERCK KGAASODIUM ACETATE TRIHYDRATE

DMF 238022010

AVANTOR PERFORMANCE MATERIALS LLCSODIUM ACETATE TRIHYDRATE

DMF 277522014

MACCO ORGANIQUES INCSODIUM ACETATE ANHYDROUS

DMF 278442013

VM CHEMICALSSODIUM ACETATE TRIHYDRATE BP

DMF 290392015

MACCO ORGANIQUES INCSODIUM ACETATE TRIHYDRATE

DMF 330292018

LUOYANG LONGMEN PHARMACEUTICAL CO LTDSODIUM ACETATE TRIHYDRATE

DMF 426652025

EMNAR PHARMA PRIVATE LTDSODIUM ACETATE

DMF 428822025

NIACET CORPInactiveSODIUM ACETATE ANHYDROUS, USP GRADE

DMF 66541986

CARDINAL HEALTH 414 LLCInactiveSODIUM ACETATE C-11 INJECTION

DMF 245602011

SIEMENS MOLECULAR IMAGING INCInactiveSODIUM ACETATE C11 INJECTION

DMF 263522012

MERCK KGAAInactiveSODIUM ACETATE ANHYDROUS

DMF 319262017

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 15, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 100MEQ/50ML (2MEQ/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 4, 2021

No patent or exclusivity listings for this strength.

#002 — 400MEQ/100ML (4MEQ/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Aug 25, 2023

#003 — 200MEQ/100ML (2MEQ/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 4, 2021

#004 — 40MEQ/20ML (2MEQ/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jan 22, 2024