Details for New Drug Application (NDA): 213516
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NDA 213516 describes TECHNETIUM TC-99M SULFUR COLLOID KIT, which is a drug marketed by Jubilant and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNETIUM TC-99M SULFUR COLLOID KIT profile page.
The generic ingredient in TECHNETIUM TC-99M SULFUR COLLOID KIT is technetium tc-99m sulfur colloid kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sulfur colloid kit profile page.
The generic ingredient in TECHNETIUM TC-99M SULFUR COLLOID KIT is technetium tc-99m sulfur colloid kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sulfur colloid kit profile page.
Summary for 213516
| Tradename: | TECHNETIUM TC-99M SULFUR COLLOID KIT |
| Applicant: | Jubilant |
| Ingredient: | technetium tc-99m sulfur colloid kit |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213516
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC-99M SULFUR COLLOID KIT | technetium tc-99m sulfur colloid kit | SOLUTION;INJECTION, ORAL | 213516 | ANDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-179 | 65174-179-01 | 1 KIT in 1 PACKAGE (65174-179-01) * 3 mL in 1 VIAL (65174-046-01) * 3 mL in 1 VIAL (65174-047-01) * 10 mL in 1 VIAL (65174-131-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION, ORAL | Strength | N/A | ||||
| Approval Date: | Nov 9, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 1, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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