Details for New Drug Application (NDA): 075706
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NDA 075706 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-one 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-one 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-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 075706
| Tradename: | LORATADINE AND PSEUDOEPHEDRINE SULFATE |
| Applicant: | P And L |
| Ingredient: | loratadine; pseudoephedrine sulfate |
| Patents: | 0 |
Pharmacology for NDA: 075706
| Mechanism of Action | Adrenergic alpha-Agonists |
Suppliers and Packaging for NDA: 075706
| 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 | 075706 | ANDA | Bayer HealthCare LLC. | 11523-0102 | 11523-0102-1 | 1 BLISTER PACK in 1 CARTON (11523-0102-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | loratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 075706 | ANDA | Bayer HealthCare LLC. | 11523-0102 | 11523-0102-2 | 1 BLISTER PACK in 1 CARTON (11523-0102-2) / 15 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: | Feb 21, 2003 | TE: | RLD: | No | |||||
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