DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 021629
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: | 23 |
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: | ➤ Sign Up | Patent Expiration: | Jun 18, 2018 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS | ||||||||
Patent: | ➤ Sign Up | Patent Expiration: | Jan 25, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS | ||||||||
Patent: | ➤ Sign Up | Patent Expiration: | Mar 22, 2022 | Product Flag? | Y | Substance Flag? | Delist Request? |
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 | ➤ Sign Up | ➤ Sign Up |
Sanofi Aventis Us | APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629-003 | Feb 24, 2009 | ➤ Sign Up | ➤ Sign Up |
Sanofi Aventis Us | APIDRA | insulin glulisine recombinant | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021629-002 | Dec 20, 2005 | ➤ Sign Up | ➤ Sign Up |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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