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Details for New Drug Application (NDA): 020785
NDA 020785 describes THALOMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug and three Paragraph IV challenges. 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: | Celgene |
| Ingredient: | thalidomide |
| Patents: | 15 |
| Formulation / Manufacturing: | see details |
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 | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Aug 28, 2018 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED 'SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY' (S.T.E.P.S.) | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Aug 28, 2018 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Oct 23, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURRENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG | ||||||||
Expired US Patents for NDA 020785
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | ➤ Sign Up | ➤ Sign Up |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | ➤ Sign Up | ➤ Sign Up |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ➤ Sign Up | ➤ Sign Up |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | ➤ Sign Up | ➤ Sign Up |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | ➤ Sign Up | ➤ Sign Up |
| Celgene | 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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