Details for New Drug Application (NDA): 203973
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NDA 203973 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, Patrin, and Rising, and is included in eighteen NDAs. It is available from nineteen 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-three 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-three suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 203973
| Tradename: | CALCITRIOL |
| Applicant: | Patrin |
| Ingredient: | calcitriol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203973
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | calcitriol | SOLUTION;ORAL | 203973 | ANDA | Patrin Pharma, Inc | 39328-042 | 39328-042-15 | 1 BOTTLE, GLASS in 1 CARTON (39328-042-15) / 15 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MCG/ML | ||||
| Approval Date: | Jul 28, 2023 | TE: | AA | RLD: | No | ||||
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