Details for New Drug Application (NDA): 077498
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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 077498
Tradename: | CETIRIZINE HYDROCHLORIDE HIVES |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 077498
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 077498
Suppliers and Packaging for NDA: 077498
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077498 | ANDA | Marlex Pharmaceuticals, Inc | 10135-762 | 10135-762-01 | 100 TABLET in 1 BOTTLE (10135-762-01) |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 077498 | ANDA | Marlex Pharmaceuticals, Inc | 10135-762 | 10135-762-03 | 300 TABLET in 1 BOTTLE (10135-762-03) |
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 | 5MG | ||||
Approval Date: | Dec 27, 2007 | TE: | RLD: | No |
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