Details for New Drug Application (NDA): 208956
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The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.
Summary for 208956
Tradename: | TRIPTODUR KIT |
Applicant: | Azurity |
Ingredient: | triptorelin pamoate |
Patents: | 1 |
Medical Subject Heading (MeSH) Categories for 208956
Suppliers and Packaging for NDA: 208956
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRIPTODUR KIT | triptorelin pamoate | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 208956 | NDA | Azurity Pharmaceuticals, Inc. | 24338-150 | 24338-150-20 | 1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | EQ 22.5MG BASE/VIAL | ||||
Approval Date: | Jun 29, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 29, 2024 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Jun 30, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? |
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