Details for New Drug Application (NDA): 205555
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NDA 205555 describes STERITALC, which is a drug marketed by Novatech Sa and is included in one NDA. It is available from one supplier. Additional details are available on the STERITALC profile page.
The generic ingredient in STERITALC is talc. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the talc profile page.
The generic ingredient in STERITALC is talc. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the talc profile page.
Summary for 205555
| Tradename: | STERITALC |
| Applicant: | Novatech Sa |
| Ingredient: | talc |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 205555
Suppliers and Packaging for NDA: 205555
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERITALC | talc | POWDER;INTRAPLEURAL | 205555 | NDA | Novatech SA | 62327-222 | 62327-222-42 | 4 VIAL, GLASS in 1 BOX (62327-222-42) / 50 mL in 1 VIAL, GLASS (62327-222-02) |
| STERITALC | talc | POWDER;INTRAPLEURAL | 205555 | NDA | Novatech SA | 62327-333 | 62327-333-43 | 4 VIAL, GLASS in 1 BOX (62327-333-43) / 10 mL in 1 VIAL, GLASS (62327-333-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAPLEURAL | Strength | 2GM/VIAL | ||||
| Approval Date: | May 1, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 1, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO DECREASE THE RECURRENCE OF MALIGNANT PLEURAL EFFUSIONS IN SYMPTOMATIC PATIENTS FOLLOWING MAXIMAL DRAINAGE OF THE PLEURAL EFFUSION | ||||||||
| Regulatory Exclusivity Expiration: | May 1, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO DECREASE THE RECURRENCE OF PNEUMOTHORAX IN ADULTS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAPLEURAL | Strength | 3GM/VIAL | ||||
| Approval Date: | May 1, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 1, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO DECREASE THE RECURRENCE OF MALIGNANT PLEURAL EFFUSIONS IN SYMPTOMATIC PATIENTS FOLLOWING MAXIMAL DRAINAGE OF THE PLEURAL EFFUSION | ||||||||
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