Details for New Drug Application (NDA): 219796
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NDA 219796 describes CALCITRIOL, which is a drug marketed by Amneal Pharms, Bionpharma, Hikma, Humanwell Puracap, Onesource Specialty, Sun Pharm, Teva, Am Regent, Fresenius Kabi Usa, Fresenius Medcl, Gland, Hospira, Long Grove Pharms, Rockwell Medcl, Sagent Pharms, Teva Parenteral, Anda Repository, and Rising, and is included in nineteen 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-two 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-two suppliers are listed for this compound. Additional details are available on the calcitriol profile page.
Summary for 219796
| Tradename: | CALCITRIOL |
| Applicant: | Humanwell Puracap |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219796
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 219796 | ANDA | EPIC PHARMA LLC | 42806-732 | 42806-732-01 | 100 CAPSULE in 1 BOTTLE (42806-732-01) |
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 219796 | ANDA | EPIC PHARMA LLC | 42806-733 | 42806-733-01 | 100 CAPSULE in 1 BOTTLE (42806-733-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
| Approval Date: | Feb 27, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Feb 27, 2026 | TE: | AB | RLD: | No | ||||
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