Details for New Drug Application (NDA): 076677
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The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 076677
Tradename: | CETIRIZINE HYDROCHLORIDE HIVES |
Applicant: | Mylan |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076677
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 076677
Suppliers and Packaging for NDA: 076677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 076677 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3635 | 0378-3635-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3635-01) |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 076677 | ANDA | Mylan Pharmaceuticals Inc. | 0378-3637 | 0378-3637-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 27, 2007 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 27, 2007 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 27, 2007 | TE: | RLD: | No |
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