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Details for New Drug Application (NDA): 021629
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NDA 021629 describes APIDRA SOLOSTAR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the APIDRA SOLOSTAR profile page.
The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.
The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.
Summary for 021629
| Tradename: | APIDRA SOLOSTAR |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | insulin glulisine recombinant |
| Patents: | 22 |
Pharmacology for NDA: 021629
| Ingredient-type | Insulin |
Suppliers and Packaging for NDA: 021629
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APIDRA | insulin glulisine recombinant | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021629 | NDA | sanofi-aventis U.S. LLC | 0088-2500 | 0088-2500-33 | 1 VIAL, GLASS in 1 CARTON (0088-2500-33) > 10 mL in 1 VIAL, GLASS |
| APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629 | NDA | sanofi-aventis U.S. LLC | 0088-2500 | 0088-2500-33 | 1 VIAL, GLASS in 1 CARTON (0088-2500-33) > 10 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 1000 UNITS/10ML (100 UNITS/ML) | ||||
| Approval Date: | Apr 16, 2004 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jan 25, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS | ||||||||
| Patent: | Start Trial | Patent Expiration: | Mar 22, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Mar 22, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS | ||||||||
Expired US Patents for NDA 021629
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | APIDRA | insulin glulisine recombinant | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021629-001 | Apr 16, 2004 | Start Trial | Start Trial |
| Sanofi Aventis Us | APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629-003 | Feb 24, 2009 | Start Trial | Start Trial |
| Sanofi Aventis Us | APIDRA | insulin glulisine recombinant | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021629-002 | Dec 20, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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