Details for New Drug Application (NDA): 204364
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NDA 204364 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin, Piramal, Rising, Stevens J, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in fourteen NDAs. It is available from sixteen suppliers. Additional details are available on the CINACALCET HYDROCHLORIDE profile page.
The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There is one drug master file entry for this compound. Seventeen 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 | EQ 30MG BASE | ||||
| Approval Date: | Dec 2, 2021 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Dec 2, 2021 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
| Approval Date: | Dec 2, 2021 | TE: | RLD: | No | |||||
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