Is there a generic for Protein hydrolysate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Protein hydrolysate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Protein hydrolysate?

AMINOSOL 5% (NDA 005932, ABBVIE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Protein hydrolysate are approved?

Protein hydrolysate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Protein hydrolysate

Protein hydrolysate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:AMINOSOL 5% · NDA 005932

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
AMINOSOL 5%	ABBVIE	NDA 005932	—	Jan 31, 1985
HYPROTIGEN 5%	B BRAUN	NDA 006170	—	Jan 10, 1984

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.

Protein hydrolysate — frequently asked questions

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

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