Details for New Drug Application (NDA): 203330
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NDA 203330 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by P And L, Taro, Dr Reddys Labs Ltd, Rising, Sun Pharm Inds, Teva, and Wockhardt, and is included in eight NDAs. It is available from thirty-eight suppliers. Additional details are available on the CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES profile page.
The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four 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 |
Pharmacology for NDA: 203330
| Mechanism of Action | Histamine H1 Receptor Antagonists |
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 | 0363-2600 | 0363-2600-04 | 1 BOTTLE, PLASTIC in 1 BOX (0363-2600-04) / 118 mL in 1 BOTTLE, PLASTIC |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 203330 | ANDA | Walgreens | 0363-2600 | 0363-2600-08 | 1 BOTTLE, PLASTIC in 1 BOX (0363-2600-08) / 237 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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