Details for New Drug Application (NDA): 021897
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NDA 021897 describes VIVITROL, which is a drug marketed by Alkermes and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VIVITROL profile page.
The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.
The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.
Summary for 021897
| Tradename: | VIVITROL |
| Applicant: | Alkermes |
| Ingredient: | naltrexone |
| Patents: | 1 |
Medical Subject Heading (MeSH) Categories for 021897
Suppliers and Packaging for NDA: 021897
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897 | NDA | Alkermes, Inc. | 65757-300 | 65757-300-01 | 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03) |
| VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897 | NDA | Alkermes, Inc. | 65757-301 | 65757-301-01 | 1 KIT in 1 CARTON (65757-301-01) * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 380MG/VIAL | ||||
| Approval Date: | Apr 13, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 15, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 15, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ALCOHOL DEPENDENCE | ||||||||
Expired US Patents for NDA 021897
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Alkermes | VIVITROL | naltrexone | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 021897-001 | Apr 13, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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