Details for New Drug Application (NDA): 078343
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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 078343
Tradename: | CETIRIZINE HYDROCHLORIDE HIVES |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078343
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078343
Suppliers and Packaging for NDA: 078343
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078343 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-183 | 43598-183-31 | 300 TABLET, FILM COATED in 1 BOTTLE (43598-183-31) |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078343 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-183 | 43598-183-55 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-183-55) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 15, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 15, 2008 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 15, 2008 | TE: | RLD: | No |
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