Details for New Drug Application (NDA): 210207
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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 210207
Tradename: | CINACALCET HYDROCHLORIDE |
Applicant: | Slate Run Pharma |
Ingredient: | cinacalcet hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210207
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 210207
Suppliers and Packaging for NDA: 210207
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 210207 | ANDA | Slate Run Pharmaceuticals | 70436-007 | 70436-007-04 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-007-04) |
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 210207 | ANDA | Slate Run Pharmaceuticals | 70436-008 | 70436-008-04 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-008-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Aug 1, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Aug 1, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Aug 1, 2018 | TE: | AB | RLD: | No |
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