Is there a generic for Loratadine; pseudoephedrine sulfate?

Yes. The FDA Orange Book lists 6 approved generic (ANDA) applications for Loratadine; pseudoephedrine sulfate, referencing the brand CLARITIN-D. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Loratadine; pseudoephedrine sulfate?

CLARITIN-D (NDA 019670, BAYER HEALTHCARE LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Loratadine; pseudoephedrine sulfate are approved?

Loratadine; pseudoephedrine sulfate is approved in the following dosage form: tablet, extended release.

FDA Orange Book · active-ingredient family

Loratadine; pseudoephedrine sulfate

Loratadine; pseudoephedrine sulfate: 2 brands, 6 generics; first approved Nov 27, 2002; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 6 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CLARITIN-DRLDRS

BAYER HEALTHCARE LLCNDA 0196702002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG;120MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

CLARITIN-D 24 HOURRLDRS

BAYER HEALTHCARE LLCNDA 0204702002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;240MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

Abbreviated applications

Generic (ANDA) products (6)

LORATADINE AND PSEUDOEPHEDRINE SULFATE

BIONPHARMAANDA 2180172024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;240MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

LORATADINE AND PSEUDOEPHEDRINE SULFATE

SUN PHARM INDS LTDANDA 0765572004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;240MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

LORATADINE AND PSEUDOEPHEDRINE SULFATE

PERRIGO PHARMA INTLANDA 0759892004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;240MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

LORATADINE AND PSEUDOEPHEDRINE SULFATE

HERITAGE PHARMAANDA 0762082004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG;120MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

LORATADINE AND PSEUDOEPHEDRINE SULFATE

P AND LANDA 0757062003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG;240MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

LORATADINE AND PSEUDOEPHEDRINE SULFATE

PERRIGO PHARMA INTLANDA 0760502003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG;120MG	TABLET, EXTENDED RELEASE	ORAL	OTC	—

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.

FDA approval span

Approval history

First approval

Nov 27, 2002

24 yr ago

Most recent approval

May 14, 2024

2 yr 2 mo ago

Approvals span 2002–2024 across 8 FDA applications.

Brand (NDA) 225%

Generic (ANDA) 675%

Loratadine; pseudoephedrine sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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