Details for New Drug Application (NDA): 021324
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NDA 021324 describes ENTOCORT EC, which is a drug marketed by Padagis Us and is included in one NDA. It is available from three suppliers. Additional details are available on the ENTOCORT EC profile page.
The generic ingredient in ENTOCORT EC is budesonide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
The generic ingredient in ENTOCORT EC is budesonide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 021324
| Tradename: | ENTOCORT EC |
| Applicant: | Padagis Us |
| Ingredient: | budesonide |
| Patents: | 0 |
Pharmacology for NDA: 021324
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021324
Suppliers and Packaging for NDA: 021324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTOCORT EC | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 021324 | NDA | Padagis US LLC | 0574-9855 | 0574-9855-10 | 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE |
| ENTOCORT EC | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 021324 | NDA | Golden State Medical Supply, Inc. | 51407-591 | 51407-591-01 | 100 CAPSULE in 1 BOTTLE (51407-591-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 3MG | ||||
| Approval Date: | Oct 2, 2001 | TE: | AB | RLD: | Yes | ||||
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