FDA Product

Loratadineantihistamine antihistamine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Loratadineantihistamine antihistamine

FDA Product Code

49349-218

Regulatory Information

NDC Product Code

49349-218

Application Number

ANDA076301

Marketing Category

C73584

Effective Date

May 20, 2013

Territorial Authority

USA

FDA Title

Perrigo Loratadine Tablets, 10 mg Drug Facts

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerREMEDYREPACK INC.

DUNS Number

829572556

Active Ingredients

Quantity: 10 mg in 1 1

Code: 7AJO3BO7QN

Class Code: ACTIB

Inactive Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

LORATADINE

Code: 7AJO3BO7QN

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