Details for New Drug Application (NDA): 211488
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The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the leuprolide mesylate profile page.
Summary for 211488
Tradename: | CAMCEVI KIT |
Applicant: | Accord |
Ingredient: | leuprolide mesylate |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211488
Generic Entry Date for 211488*:
Constraining patent/regulatory exclusivity:
Dosage:
EMULSION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211488
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 211488
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CAMCEVI KIT | leuprolide mesylate | EMULSION;SUBCUTANEOUS | 211488 | NDA | Accord BioPharma, Inc. | 69448-014 | 69448-014-63 | 1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | EMULSION;SUBCUTANEOUS | Strength | EQ 42MG BASE | ||||
Approval Date: | May 25, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 25, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 16, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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