Details for New Drug Application (NDA): 208368
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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 208368
Tradename: | CINACALCET HYDROCHLORIDE |
Applicant: | Dr Reddys |
Ingredient: | cinacalcet hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208368
Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 208368
Suppliers and Packaging for NDA: 208368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 208368 | ANDA | Dr. Reddys Laboratories Inc | 43598-367 | 43598-367-05 | 500 TABLET in 1 BOTTLE (43598-367-05) |
CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 208368 | ANDA | Dr. Reddys Laboratories Inc | 43598-367 | 43598-367-30 | 30 TABLET in 1 BOTTLE (43598-367-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Sep 18, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Sep 18, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
Approval Date: | Sep 18, 2020 | TE: | AB | RLD: | No |
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