FDA Orange Book
Generic for Dtic-dome
Dtic-dome contains dacarbazine. 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 Dtic-dome is dacarbazine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Dtic-dome products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/VIAL | Discontinued | None | 1 | None |
| injectable, injection | 200MG/VIAL | Discontinued | None | 3 | AP |
NDA 017575, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dacarbazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MEITHEAL PHARMACEUTICALS INC | 075259 | AP (A-rated, therapeutically equivalent) | August 27, 1998 | 200MG/VIAL |
| FRESENIUS KABI USA LLC | 075371 | None (No TE code listed) | August 27, 1999 | 100MG/VIAL, 200MG/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 075812 | AP (A-rated, therapeutically equivalent) | June 15, 2001 | 200MG/VIAL |
Questions
Is there a generic for Dtic-dome?
Yes. The generic name for Dtic-dome is dacarbazine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Dtic-dome?
The active ingredient in Dtic-dome is dacarbazine, 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.