Details for New Drug Application (NDA): 204364
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The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 204364
Tradename: | CINACALCET HYDROCHLORIDE |
Applicant: | Stevens J |
Ingredient: | cinacalcet hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204364
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 204364
Suppliers and Packaging for NDA: 204364
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 204364 | ANDA | Amneal Pharmaceuticals LLC | 65162-155 | 65162-155-03 | 30 TABLET in 1 BOTTLE (65162-155-03) |
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 204364 | ANDA | Amneal Pharmaceuticals LLC | 65162-155 | 65162-155-10 | 100 TABLET in 1 BOTTLE (65162-155-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Dec 2, 2021 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Dec 2, 2021 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 90MG | ||||
Approval Date: | Dec 2, 2021 | TE: | RLD: | No |
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