Is Alclometasone Dipropionate still available?

Yes. Alclometasone Dipropionate (ANDA 076884) is listed with marketing status Prescription in the FDA Orange Book.

What is Alclometasone Dipropionate a generic of?

Alclometasone Dipropionate is a generic (ANDA 076884) containing Alclometasone Dipropionate. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Alclometasone Dipropionate's TE code AB mean?

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

What is Alclometasone Dipropionate's FDA application number?

Alclometasone Dipropionate is approved under ANDA 076884, held by Fougera Pharms.

Orange Book product · Generic (ANDA)

Alclometasone Dipropionate

Generic (ANDA)ANDA 076884TE AB Fougera Pharms

Approved

Jul 18, 2005

Application

Generic (ANDA)

TE code

Listed patents

Alclometasone Dipropionate (Alclometasone Dipropionate) is a generic drug approved under an ANDA (076884) in 2005, marketed by Fougera Pharms. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Jul 18, 2005
21 yr 4 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ALCLOMETASONE DIPROPIONATE

Strength

0.05%

Dosage form

OINTMENT

Route

TOPICAL

TE code

Application

ANDA 076884

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

Generic (ANDA) of Alclometasone Dipropionate

View full Alclometasone Dipropionate 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.

Alclometasone Dipropionate — 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 Alclometasone Dipropionate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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