Details for New Drug Application (NDA): 075989
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NDA 075989 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 075989
| Tradename: | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
| Applicant: | Perrigo Pharma Intl |
| Ingredient: | loratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 075989
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 075989
| 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 | 075989 | ANDA | Walgreen Company | 0363-2010 | 0363-2010-22 | 15 BLISTER PACK in 1 CARTON (0363-2010-22) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 075989 | ANDA | Kroger Company | 30142-846 | 30142-846-22 | 15 BLISTER PACK in 1 CARTON (30142-846-22) / 1 TABLET, 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: | Mar 4, 2004 | TE: | RLD: | No | |||||
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