FDA Orange Book
Generic for Declomycin
Declomycin contains demeclocycline. 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 Declomycin is demeclocycline. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Declomycin products the Orange Book lists.
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Declomycin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 0 | None |
| syrup, oral | 75MG/5ML | Discontinued | None | 0 | None |
| tablet, oral | 150MG | Discontinued | None | 3 | AB |
| tablet, oral | 300MG | Discontinued | None | 3 | AB |
| tablet, oral | 75MG | Discontinued | None | 0 | None |
NDA 050262, 050257, 050261, held by LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic demeclocycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICAL | 065425 | AB (A-rated, therapeutically equivalent) | February 27, 2008 | 150MG, 300MG |
| EPIC PHARMA LLC | 065389 | AB (A-rated, therapeutically equivalent) | December 1, 2008 | 150MG, 300MG |
| EPIC PHARMA LLC | 065447 | AB (A-rated, therapeutically equivalent) | August 18, 2015 | 150MG, 300MG |
Questions
Is there a generic for Declomycin?
Yes. The generic name for Declomycin is demeclocycline. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Declomycin products the Orange Book lists.
What is the generic name for Declomycin?
The active ingredient in Declomycin is demeclocycline, 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.