Details for New Drug Application (NDA): 040541
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NDA 040541 describes SOTRADECOL, which is a drug marketed by Elkins Sinn and Mylan Institutional and is included in two NDAs. It is available from two suppliers. Additional details are available on the SOTRADECOL profile page.
The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium tetradecyl sulfate profile page.
The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium tetradecyl sulfate profile page.
Summary for 040541
| Tradename: | SOTRADECOL |
| Applicant: | Mylan Institutional |
| Ingredient: | sodium tetradecyl sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 040541
Suppliers and Packaging for NDA: 040541
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1562 | 51662-1562-1 | 2 mL in 1 VIAL, MULTI-DOSE (51662-1562-1) |
| SOTRADECOL | sodium tetradecyl sulfate | INJECTABLE;INJECTION | 040541 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1563 | 51662-1563-1 | 2 mL in 1 VIAL, MULTI-DOSE (51662-1563-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/2ML (10MG/ML) | ||||
| Approval Date: | Nov 12, 2004 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 60MG/2ML (30MG/ML) | ||||
| Approval Date: | Nov 12, 2004 | TE: | AP | RLD: | No | ||||
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