Details for New Drug Application (NDA): 212785
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NDA 212785 describes INDIUM IN-111 PENTETREOTIDE KIT, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. It is available from one supplier. Additional details are available on the INDIUM IN-111 PENTETREOTIDE KIT profile page.
The generic ingredient in INDIUM IN-111 PENTETREOTIDE KIT is indium in-111 pentetreotide kit. There are twenty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 pentetreotide kit profile page.
The generic ingredient in INDIUM IN-111 PENTETREOTIDE KIT is indium in-111 pentetreotide kit. There are twenty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indium in-111 pentetreotide kit profile page.
Summary for 212785
| Tradename: | INDIUM IN-111 PENTETREOTIDE KIT |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | indium in-111 pentetreotide kit |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INDIUM IN-111 PENTETREOTIDE KIT | indium in-111 pentetreotide kit | INJECTABLE;INJECTION | 212785 | ANDA | Sun Pharmaceutical Industries, Inc. | 45567-0755 | 45567-0755-3 | 1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3mCi/ML | ||||
| Approval Date: | Jul 1, 2024 | TE: | AP | RLD: | No | ||||
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