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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209784
Company: SANDOZ INC

Products on ANDA 209784

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209784

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/23/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209784Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/28/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209784

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AKOVAZ	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	208289	EXELA PHARMA
CORPHEDRA	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208943	PAR STERILE PRODUCTS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	215825	AGGREGA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	208609	AKORN
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212932	AMNEAL
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212649	DR REDDYS
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214579	EUGIA PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209646	FRESENIUS KABI USA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216146	GLAND PHARMA LTD
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214334	HIKMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216129	MANKIND PHARMA
EPHEDRINE SULFATE	EPHEDRINE SULFATE	50MG/ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	209784	SANDOZ INC

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