Details for New Drug Application (NDA): 090455
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NDA 090455 describes ERGOCALCIFEROL, which is a drug marketed by Chartwell Rx, Puracap Pharm Llc, Sigmapharm Labs Llc, Strides Pharma, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from eighteen suppliers. Additional details are available on the ERGOCALCIFEROL profile page.
The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 090455
| Tradename: | ERGOCALCIFEROL |
| Applicant: | Strides Pharma |
| Ingredient: | ergocalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090455
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERGOCALCIFEROL | ergocalciferol | CAPSULE;ORAL | 090455 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-809 | 23155-809-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (23155-809-01) |
| ERGOCALCIFEROL | ergocalciferol | CAPSULE;ORAL | 090455 | ANDA | AvPAK | 50268-297 | 50268-297-15 | 50 BLISTER PACK in 1 BOX (50268-297-15) / 1 CAPSULE in 1 BLISTER PACK (50268-297-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50,000 IU | ||||
| Approval Date: | Aug 3, 2010 | TE: | AA | RLD: | No | ||||
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