Details for New Drug Application (NDA): 211030
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NDA 211030 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Strides Pharma, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland Pharma Ltd, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the CALCITRIOL profile page.
The generic ingredient in CALCITRIOL 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 CALCITRIOL 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 211030
| Tradename: | CALCITRIOL |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211030
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | calcitriol | INJECTABLE;INJECTION | 211030 | ANDA | Gland Pharma Limited | 68083-316 | 68083-316-10 | 10 VIAL in 1 CARTON (68083-316-10) / 1 mL in 1 VIAL |
| CALCITRIOL | calcitriol | INJECTABLE;INJECTION | 211030 | ANDA | FOSUN PHARMA USA INC | 72266-251 | 72266-251-10 | 10 VIAL in 1 CARTON (72266-251-10) / 1 mL in 1 VIAL (72266-251-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.001MG/ML | ||||
| Approval Date: | Feb 3, 2020 | TE: | AP | RLD: | No | ||||
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