Details for New Drug Application (NDA): 020785
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NDA 020785 describes THALOMID, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from one supplier. Additional details are available on the THALOMID profile page.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
Summary for 020785
| Tradename: | THALOMID |
| Applicant: | Bristol-myers |
| Ingredient: | thalidomide |
| Patents: | 0 |
Pharmacology for NDA: 020785
| Physiological Effect | Decreased Immunologically Active Molecule Activity |
Medical Subject Heading (MeSH) Categories for 020785
Suppliers and Packaging for NDA: 020785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THALOMID | thalidomide | CAPSULE;ORAL | 020785 | NDA | Celgene Corporation | 59572-205 | 59572-205-94 | 10 BLISTER PACK in 1 BOX (59572-205-94) / 28 CAPSULE in 1 BLISTER PACK (59572-205-14) |
| THALOMID | thalidomide | CAPSULE;ORAL | 020785 | NDA | Celgene Corporation | 59572-205 | 59572-205-97 | 10 BLISTER PACK in 1 BOX (59572-205-97) / 1 CAPSULE in 1 BLISTER PACK (59572-205-17) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 16, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 17, 2003 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 17, 2003 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020785
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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