Is there a generic for Atropine?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Atropine, referencing the brand ATROPEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Atropine?

ATROPEN (NDA 017106, 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 are approved?

Atropine is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Atropine

Atropine is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ATROPEN · NDA 017106

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
ATROPENRLD×4	MMT	NDA 017106	—	Sep 17, 2004
ATROPINE (AUTOINJECTOR)	RAFA LABS LTD	NDA 212319	—	Jul 09, 2018

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
ATROPINE	ABBVIE	ANDA 071295	—	Jan 30, 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.

Atropine — frequently asked questions

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

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