Details for New Drug Application (NDA): 209226
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NDA 209226 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 are twenty-four drug master file entries 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 are twenty-four drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.
Summary for 209226
| Tradename: | CINACALCET HYDROCHLORIDE |
| Applicant: | Strides Pharma |
| Ingredient: | cinacalcet hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 209226
| Mechanism of Action | Increased Calcium-sensing Receptor Sensitivity |
Medical Subject Heading (MeSH) Categories for 209226
Suppliers and Packaging for NDA: 209226
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 209226 | ANDA | Major Pharmaceuticals | 0904-7502 | 0904-7502-04 | 30 BLISTER PACK in 1 CARTON (0904-7502-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| CINACALCET HYDROCHLORIDE | cinacalcet hydrochloride | TABLET;ORAL | 209226 | ANDA | AvPAK | 50268-188 | 50268-188-12 | 20 BLISTER PACK in 1 BOX (50268-188-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-188-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 60MG BASE | ||||
| Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 90MG BASE | ||||
| Approval Date: | Apr 30, 2018 | TE: | AB | RLD: | No | ||||
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