Is Activella still available?

Activella (NDA 020907) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Activella have a generic?

Yes. The Orange Book lists 8 approved generic (ANDA) applications sharing Activella's active ingredient (Estradiol; Norethindrone Acetate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Activella's FDA application number?

Activella is approved under NDA 020907, held by Amneal.

Orange Book product · Brand (NDA)

Activella

Estradiol; Norethindrone Acetate

Brand (NDA)NDA 020907DiscontinuedRLD Amneal

Approved

Dec 28, 2006

Application

Brand (NDA)

TE code

Not listed

Listed patents

Activella (Estradiol; Norethindrone Acetate) is Amneal's brand-name drug, approved by the FDA under NDA 020907 in 2006. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 8 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 28, 2006
19 yr 10 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020907

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 020907

1MG;0.5MGTABLET

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Estradiol; Norethindrone Acetate family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Activella — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Estradiol; Norethindrone Acetate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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