Details for New Drug Application (NDA): 018044
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NDA 018044 describes ROCALTROL, which is a drug marketed by Esjay Pharma and is included in two NDAs. It is available from three suppliers. Additional details are available on the ROCALTROL profile page.
The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
The generic ingredient in ROCALTROL is calcitriol. There are ten drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 018044
| Tradename: | ROCALTROL |
| Applicant: | Esjay Pharma |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 018044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROCALTROL | calcitriol | CAPSULE;ORAL | 018044 | NDA | Validus Pharmaceuticals LLC | 30698-143 | 30698-143-01 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-01) |
| ROCALTROL | calcitriol | CAPSULE;ORAL | 018044 | NDA | Validus Pharmaceuticals LLC | 30698-143 | 30698-143-23 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (30698-143-23) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 018044
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-002 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| Esjay Pharma | ROCALTROL | calcitriol | CAPSULE;ORAL | 018044-001 | Approved Prior to Jan 1, 1982 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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