Details for New Drug Application (NDA): 208994
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NDA 208994 describes TECHNETIUM TC99M MERTIATIDE KIT, which is a drug marketed by Medi-radiopharma and Sun Pharm Inds Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the TECHNETIUM TC99M MERTIATIDE KIT profile page.
The generic ingredient in TECHNETIUM TC99M MERTIATIDE KIT is technetium tc-99m mertiatide kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m mertiatide kit profile page.
The generic ingredient in TECHNETIUM TC99M MERTIATIDE KIT is technetium tc-99m mertiatide kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m mertiatide kit profile page.
Summary for 208994
| Tradename: | TECHNETIUM TC99M MERTIATIDE KIT |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | technetium tc-99m mertiatide kit |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC99M MERTIATIDE KIT | technetium tc-99m mertiatide kit | INJECTABLE;INJECTION | 208994 | ANDA | Sun Pharmaceutical Industries, Inc. | 45567-0655 | 45567-0655-1 | 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Jul 12, 2019 | TE: | AP | RLD: | No | ||||
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