FDA Orange Book
Generic for Isopto Atropine
Isopto Atropine contains atropine. 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 Isopto Atropine is atropine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2.
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Isopto Atropine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 1% | Marketed (Rx) | AT2 | 7 | AT1, AT2 |
NDA 208151, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atropine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 215624 | AT1 (A-rated, therapeutically equivalent) | November 26, 2021 | 1% |
| AMNEAL EU LTD | 214752 | AT1 (A-rated, therapeutically equivalent) | July 14, 2022 | 1% |
| MANKIND PHARMA LTD | 218148 | AT1 (A-rated, therapeutically equivalent) | January 8, 2024 | 1% |
| SOMERSET THERAPEUTICS LLC | 217791 | AT2 (A-rated, therapeutically equivalent) | April 29, 2024 | 1% |
| SOMERSET THERAPEUTICS LLC | 215618 | AT1 (A-rated, therapeutically equivalent) | July 1, 2024 | 1% |
| EDENBRIDGE PHARMACEUTICALS LLC | 219013 | AT1 (A-rated, therapeutically equivalent) | April 15, 2026 | 1% |
| GLAND PHARMA LTD | 219996 | AT1 (A-rated, therapeutically equivalent) | July 31, 2026 | 1% |
Isopto Atropine NDC codes
Questions
Is there a generic for Isopto Atropine?
Yes. The generic name for Isopto Atropine is atropine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2.
What is the generic name for Isopto Atropine?
The active ingredient in Isopto Atropine is atropine, 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.