Details for New Drug Application (NDA): 207008
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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 207008
Tradename: | CINACALCET HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | cinacalcet hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207008
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 207008
Suppliers and Packaging for NDA: 207008
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 207008 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-379 | 47335-379-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-379-83) |
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 207008 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-380 | 47335-380-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-380-83) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Oct 11, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Oct 11, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Oct 11, 2018 | TE: | AB | RLD: | No |
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