Details for New Drug Application (NDA): 078780
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The generic ingredient in CETIRIZINE HYDROCHLORIDE HIVES RELIEF 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 078780
Tradename: | CETIRIZINE HYDROCHLORIDE HIVES RELIEF |
Applicant: | Amneal Pharms Ny |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078780
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 078780
Suppliers and Packaging for NDA: 078780
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078780 | ANDA | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-129 | 55910-129-45 | 1 BOTTLE, PLASTIC in 1 BOX (55910-129-45) / 45 TABLET in 1 BOTTLE, PLASTIC |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | TABLET;ORAL | 078780 | ANDA | P & L Development, LLC | 59726-129 | 59726-129-03 | 1 BOTTLE, PLASTIC in 1 BOX (59726-129-03) / 300 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 21, 2010 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 21, 2010 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 21, 2010 | TE: | RLD: | No |
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