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 Ltd, Mylan, Slate Run Pharma, Stevens J, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in fourteen NDAs. It is available from eighteen suppliers. Additional details are available on the CINACALCET HYDROCHLORIDE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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