Is there a generic for Atropine; pralidoxime chloride?

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

What is the reference-listed drug for Atropine; pralidoxime chloride?

DUODOTE (NDA 021983, MMT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Atropine; pralidoxime chloride are approved?

Atropine; pralidoxime chloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Atropine; pralidoxime chloride

Atropine; pralidoxime chloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DUODOTE · NDA 021983

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
DUODOTERLD	MMT	NDA 021983	—	Sep 28, 2006
ATNAA	US ARMY	NDA 021175	—	Jan 17, 2002

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.

Atropine; pralidoxime chloride — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo