Details for New Drug Application (NDA): 022335
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NDA 022335 describes TECHNEGAS KIT, which is a drug marketed by Cyclomedica and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNEGAS KIT profile page.
The generic ingredient in TECHNEGAS KIT is technetium tc-99m labeled carbon. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m labeled carbon profile page.
The generic ingredient in TECHNEGAS KIT is technetium tc-99m labeled carbon. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m labeled carbon profile page.
Summary for 022335
| Tradename: | TECHNEGAS KIT |
| Applicant: | Cyclomedica |
| Ingredient: | technetium tc-99m labeled carbon |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022335
Generic Entry Date for 022335*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
AEROSOL;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 022335
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNEGAS KIT | technetium tc-99m labeled carbon | AEROSOL;INHALATION | 022335 | NDA | Cyclomedica Australia Pty Limited | 73814-987 | 73814-987-20 | 1 KIT in 1 CARTON (73814-987-20) * 1 in 1 CARTON (GS1:19340598000050) * 50 AEROSOL in 1 CARTON (73814-986-20) |
| TECHNEGAS KIT | technetium tc-99m labeled carbon | AEROSOL;INHALATION | 022335 | NDA | Cyclomedica Australia Pty Limited | 73814-989 | 73814-989-20 | 1 KIT in 1 CARTON (73814-989-20) * 50 AEROSOL in 1 CARTON (73814-986-20) * 50 in 1 CARTON (GS1:19340598000036) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL;INHALATION | Strength | N/A | ||||
| Approval Date: | Sep 29, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 29, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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