Is there a generic for Manganese sulfate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Manganese sulfate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Manganese sulfate?

MANGANESE SULFATE (NDA 019228, ABRAXIS PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Manganese sulfate are approved?

Manganese sulfate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Manganese sulfate

Manganese sulfate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MANGANESE SULFATE · NDA 019228

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MANGANESE SULFATERLD	ABRAXIS PHARM	NDA 019228	—	May 05, 1987

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Manganese sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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