FDA Orange Book

Generic for Salagen

Salagen contains pilocarpine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Salagen is pilocarpine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Salagen products in the Orange Book

Salagen products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	5MG	Marketed (Rx)	AB	4	AB
tablet, oral	7.5MG	Marketed (Rx)	AB	4	AB

NDA 020237, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic pilocarpine

Approved generic versions of Salagen
Company	ANDA	TE code	Approved	Strengths
INNOGENIX LLC	076963	AB (A-rated, therapeutically equivalent)	December 22, 2004	5MG, 7.5MG
LANNETT CO INC	077220	AB (A-rated, therapeutically equivalent)	October 14, 2005	5MG, 7.5MG
IMPAX LABORATORIES INC	077248	AB (A-rated, therapeutically equivalent)	March 31, 2006	5MG, 7.5MG
QUAGEN PHARMACEUTICALS LLC	212377	AB (A-rated, therapeutically equivalent)	August 13, 2019	5MG, 7.5MG

Salagen NDC codes

Questions

Is there a generic for Salagen?

Yes. The generic name for Salagen is pilocarpine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Salagen?

The active ingredient in Salagen is pilocarpine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.