Details for New Drug Application (NDA): 040541
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The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There are one thousand four hundred and seventy-two drug master file entries 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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