Details for New Drug Application (NDA): 091004
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NDA 091004 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 seventeen 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-two 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-two suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.
Summary for 091004
| Tradename: | ERGOCALCIFEROL |
| Applicant: | Sigmapharm Labs Llc |
| Ingredient: | ergocalciferol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERGOCALCIFEROL | ergocalciferol | CAPSULE;ORAL | 091004 | ANDA | Proficient Rx LP | 63187-064 | 63187-064-30 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-064-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 50,000 IU | ||||
| Approval Date: | Jul 14, 2010 | TE: | RLD: | No | |||||
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