Is Bactroban still available?

Bactroban (NDA 050746) 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 A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.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 Bactroban have a generic?

Yes. The Orange Book lists 6 approved generic (ANDA) applications sharing Bactroban's active ingredient (Mupirocin Calcium). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Bactroban's FDA application number?

Bactroban is approved under NDA 050746, held by Glaxosmithkline.

Orange Book product · Brand (NDA)

Bactroban

Mupirocin Calcium

Brand (NDA)NDA 050746DiscontinuedRLD Glaxosmithkline

Approved

Dec 11, 1997

Application

Brand (NDA)

TE code

Not listed

Listed patents

Bactroban (Mupirocin Calcium) is Glaxosmithkline's brand-name drug, approved by the FDA under NDA 050746 in 1997. 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 Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 6 approved generics share this drug's active ingredient.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 11, 1997
29 yr ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

MUPIROCIN CALCIUM

Strength

EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CREAM

Route

TOPICAL

TE code

Not listed

Application

NDA 050746

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 Mupirocin Calcium 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.

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

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