Details for New Drug Application (NDA): 215049

NDA 215049 describes DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM, which is a drug marketed by Anda Repository and Annora Pharma and is included in two NDAs. It is available from two suppliers. Additional details are available on the DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM profile page.

The generic ingredient in DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

Summary for 215049

Tradename:	DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Applicant:	Annora Pharma
Ingredient:	diatrizoate meglumine; diatrizoate sodium
Patents:	0

Pharmacology for NDA: 215049

Mechanism of Action

X-Ray Contrast Activity

Suppliers and Packaging for NDA: 215049

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	215049	ANDA	Camber Pharmaceuticals, Inc.	31722-019	31722-019-31	24 BOTTLE in 1 BOX (31722-019-31) / 30 mL in 1 BOTTLE
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	215049	ANDA	Camber Pharmaceuticals, Inc.	31722-019	31722-019-32	12 BOTTLE in 1 BOX (31722-019-32) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL, RECTAL			Strength	66%;10%
Approval Date:	Nov 17, 2023	TE:	AA	RLD:	No

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