Is Alphagan P still available?

Yes. Alphagan P (NDA 021770) is listed with marketing status Prescription in the FDA Orange Book.

Does Alphagan P have a generic?

Yes. The Orange Book lists 22 approved generic (ANDA) applications sharing Alphagan P's active ingredient (Brimonidine Tartrate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Alphagan P's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Alphagan P substitutable for its reference brand with no expected difference in clinical effect.

What is Alphagan P's FDA application number?

Alphagan P is approved under NDA 021770, held by Abbvie.

Orange Book product · Brand (NDA)

Alphagan P

Brimonidine Tartrate

Brand (NDA)NDA 021770TE ABRLD Abbvie

Approved

Aug 19, 2005

Application

Brand (NDA)

TE code

Listed patents

Alphagan P (Brimonidine Tartrate) is Abbvie's brand-name drug, approved by the FDA under NDA 021770 in 2005. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 22 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.
Aug 19, 2005
21 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

BRIMONIDINE TARTRATE

Strength

0.1%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Application

NDA 021770

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 Brimonidine Tartrate 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.

Alphagan P — 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 Brimonidine Tartrate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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