FDA Orange Book
Generic for Razadyne ER
Razadyne ER contains galantamine. 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 Razadyne ER is galantamine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Razadyne ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 16MG BASE | Discontinued | None | 4 | AB |
| capsule, extended release, oral | EQ 24MG BASE | Discontinued | None | 4 | AB |
| capsule, extended release, oral | EQ 8MG BASE | Discontinued | None | 4 | AB |
NDA 021615, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic galantamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 078189 | AB (A-rated, therapeutically equivalent) | September 15, 2008 | EQ 16MG BASE, EQ 24MG BASE, EQ 8MG BASE |
| WATSON LABORATORIES INC | 079028 | AB (A-rated, therapeutically equivalent) | December 15, 2008 | EQ 16MG BASE, EQ 24MG BASE, EQ 8MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090178 | AB (A-rated, therapeutically equivalent) | February 2, 2011 | EQ 16MG BASE, EQ 24MG BASE, EQ 8MG BASE |
| AUROBINDO PHARMA LTD | 204895 | AB (A-rated, therapeutically equivalent) | August 5, 2016 | EQ 16MG BASE, EQ 24MG BASE, EQ 8MG BASE |
Questions
Is there a generic for Razadyne ER?
Yes. The generic name for Razadyne ER is galantamine. 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 Razadyne ER?
The active ingredient in Razadyne ER is galantamine, 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.