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Details for New Drug Application (NDA): 203330
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The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. Ninety-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 203330
Tradename: | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES |
Applicant: | P And L |
Ingredient: | fexofenadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203330
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 203330 | ANDA | Walgreens | 0363-9230 | 0363-9230-04 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9230-04) > 118 mL in 1 BOTTLE, PLASTIC |
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 203330 | ANDA | EQUATE (Wal-Mart Stores, Inc.) | 49035-208 | 49035-208-04 | 1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) > 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
Approval Date: | Nov 18, 2014 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
Approval Date: | Nov 18, 2014 | TE: | RLD: | No |
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