Is there a generic for Cryptenamine acetates?

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

What is the reference-listed drug for Cryptenamine acetates?

UNITENSEN (NDA 008814, MEDPOINTE PHARM HLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cryptenamine acetates are approved?

Cryptenamine acetates is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cryptenamine acetates

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

Reference-listed drug:UNITENSEN · NDA 008814

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
UNITENSEN	MEDPOINTE PHARM HLC	NDA 008814	—	Approved Prior to Jan 1, 1982

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.

Cryptenamine acetates — frequently asked questions

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

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