Details for New Drug Application (NDA): 075765
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NDA 075765 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 075765
| Tradename: | CALCITRIOL |
| Applicant: | Teva |
| Ingredient: | calcitriol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 075765 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7352 | 0093-7352-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7352-01) |
| CALCITRIOL | calcitriol | CAPSULE;ORAL | 075765 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7353 | 0093-7353-01 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0093-7353-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.25MCG | ||||
| Approval Date: | Oct 12, 2001 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.5MCG | ||||
| Approval Date: | Oct 12, 2001 | TE: | AB | RLD: | No | ||||
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