Details for New Drug Application (NDA): 211488
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NDA 211488 describes CAMCEVI KIT, which is a drug marketed by Accord and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CAMCEVI KIT profile page.
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.
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: | 10,646,572 | Patent Expiration: | Jan 16, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,717,555 | Patent Expiration: | Jan 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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