Details for New Drug Application (NDA): 212279
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NDA 212279 describes EXEM FOAM KIT, which is a drug marketed by Giskit and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the EXEM FOAM KIT profile page.
The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the air polymer-type a profile page.
The generic ingredient in EXEM FOAM KIT is air polymer-type a. There are thirty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the air polymer-type a profile page.
Summary for 212279
| Tradename: | EXEM FOAM KIT |
| Applicant: | Giskit |
| Ingredient: | air polymer-type a |
| Patents: | 3 |
Suppliers and Packaging for NDA: 212279
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXEM FOAM KIT | air polymer-type a | FOAM;INTRAUTERINE | 212279 | NDA | GISKIT PHARMA B.V. | 73254-310 | 73254-310-01 | 1 KIT in 1 CARTON (73254-310-01) * 5 mL in 1 SYRINGE, PLASTIC * 5 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOAM;INTRAUTERINE | Strength | 10ML | ||||
| Approval Date: | Nov 7, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 7, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 15, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE IN SONOHYSTEROSALPINOGRAPHY TO ASSESS FALLOPIAN TUBE PATENCY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE IN SONOHYSTEROSALPINOGRAPHY TO ASSESS FALLOPIAN TUBE PATENCY | ||||||||
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