Details for New Drug Application (NDA): 075706
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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 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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