FDA Orange Book
Is there a generic for Premphase 14/14?
Premphase 14/14 contains medroxyprogesterone acetate and estrogens conjugated. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Premphase 14/14 (medroxyprogesterone acetate and estrogens conjugated).
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Premphase 14/14 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.625MG,0.625MG;N/A,5MG | Marketed (Rx) | None | 0 | None |
NDA 020527, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Premphase 14/14 NDC codes
Questions
Is there a generic for Premphase 14/14?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Premphase 14/14 (medroxyprogesterone acetate and estrogens conjugated).
What is the generic name for Premphase 14/14?
The active ingredient in Premphase 14/14 is medroxyprogesterone acetate and estrogens conjugated, 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.