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Details for New Drug Application (NDA): 021629
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 thirty-nine 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 thirty-nine 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;IV (INFUSION), SUBCUTANEOUS | 021629 | NDA | Sanofi-Aventis U.S. LLC | 0088-2500 | N | 0088-2500-33 |
| APIDRA SOLOSTAR | insulin glulisine recombinant | INJECTABLE;SUBCUTANEOUS | 021629 | NDA | Sanofi-Aventis U.S. LLC | 0088-2500 | N | 0088-2500-33 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION), 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? | ||
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