Details for New Drug Application (NDA): 076557
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NDA 076557 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Bionpharma, Heritage Pharma, P And L, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in six NDAs. It is available from thirty-two suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.
The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 076557
| Tradename: | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
| Applicant: | Sun Pharm Inds Ltd |
| Ingredient: | loratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 076557
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 076557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 076557 | ANDA | Walgreen Company | 0363-0725 | 0363-0725-15 | 1 BLISTER PACK in 1 CARTON (0363-0725-15) / 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 076557 | ANDA | Walgreen Company | 0363-0725 | 0363-0725-56 | 1 BLISTER PACK in 1 CARTON (0363-0725-56) / 5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG;240MG | ||||
| Approval Date: | Sep 22, 2004 | TE: | RLD: | No | |||||
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