FDA Orange Book
Generic for Protostat
Protostat contains metronidazole. 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 Protostat is metronidazole. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Protostat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Discontinued | None | 11 | AB |
| tablet, oral | 500MG | Discontinued | None | 11 | AB |
NDA 018871, held by ORTHO MCNEIL PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic metronidazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 070027 | AB (A-rated, therapeutically equivalent) | November 6, 1984 | 250MG |
| PLIVA INC | 070033 | AB (A-rated, therapeutically equivalent) | December 6, 1984 | 500MG |
| WATSON LABORATORIES INC | 070035 | AB (A-rated, therapeutically equivalent) | December 20, 1984 | 250MG |
| WATSON LABORATORIES INC | 070044 | AB (A-rated, therapeutically equivalent) | February 8, 1985 | 500MG |
| INNOGENIX LLC | 070772 | AB (A-rated, therapeutically equivalent) | July 16, 1986 | 250MG, 500MG |
| ALEMBIC PHARMACEUTICALS LTD | 079067 | AB (A-rated, therapeutically equivalent) | March 13, 2009 | 250MG, 500MG |
| UNICHEM LABORATORIES LTD | 203458 | AB (A-rated, therapeutically equivalent) | January 22, 2014 | 250MG, 500MG |
| AUROBINDO PHARMA LTD | 203974 | AB (A-rated, therapeutically equivalent) | May 29, 2015 | 250MG, 500MG |
| SOMERSET THERAPEUTICS LLC | 205245 | AB (A-rated, therapeutically equivalent) | September 23, 2015 | 250MG, 500MG |
| NOVITIUM PHARMA LLC | 208162 | AB (A-rated, therapeutically equivalent) | May 25, 2016 | 250MG, 500MG |
| CADILA HEALTHCARE LTD | 206560 | AB (A-rated, therapeutically equivalent) | November 16, 2016 | 250MG, 500MG |
| ALEMBIC PHARMACEUTICALS LTD | 208681 | AB (A-rated, therapeutically equivalent) | June 20, 2017 | 250MG, 500MG |
| CADILA PHARMACEUTICALS LTD | 209794 | AB (A-rated, therapeutically equivalent) | December 12, 2017 | 250MG, 500MG |
Questions
Is there a generic for Protostat?
Yes. The generic name for Protostat is metronidazole. 11 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 Protostat?
The active ingredient in Protostat is metronidazole, 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.