Details for New Drug Application (NDA): 204507
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NDA 204507 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, and Wockhardt, and is included in six NDAs. It is available from forty-six suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE HIVES profile page.
The generic ingredient in 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 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 204507
| Tradename: | FEXOFENADINE HYDROCHLORIDE HIVES |
| Applicant: | Sciegen Pharms Inc |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204507
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 204507
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 204507 | ANDA | Walgreens | 0363-0904 | 0363-0904-05 | 5 BLISTER PACK in 1 CARTON (0363-0904-05) / 1 TABLET, COATED in 1 BLISTER PACK |
| FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 204507 | ANDA | Walgreens | 0363-0904 | 0363-0904-15 | 15 BLISTER PACK in 1 CARTON (0363-0904-15) / 1 TABLET, COATED in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | RLD: | No | |||||
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