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Details for New Drug Application (NDA): 022058
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NDA 022058 describes SUPPRELIN LA, which is a drug marketed by Endo Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the SUPPRELIN LA profile page.
The generic ingredient in SUPPRELIN LA is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.
The generic ingredient in SUPPRELIN LA is histrelin acetate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the histrelin acetate profile page.
Summary for 022058
| Tradename: | SUPPRELIN LA |
| Applicant: | Endo Pharm |
| Ingredient: | histrelin acetate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 022058
Generic Entry Date for 022058*:
Constraining patent/regulatory exclusivity:
Dosage:
IMPLANT;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: 022058
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 022058
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUPPRELIN LA | histrelin acetate | IMPLANT;SUBCUTANEOUS | 022058 | NDA | Endo Pharmaceuticals Inc. | 67979-002 | 67979-002-01 | 1 VIAL, GLASS in 1 CARTON (67979-002-01) > 1 IMPLANT in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;SUBCUTANEOUS | Strength | 50MG | ||||
| Approval Date: | May 3, 2007 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Free Forever Trial | Patent Expiration: | Jun 16, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY | ||||||||
Expired US Patents for NDA 022058
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Endo Pharm | SUPPRELIN LA | histrelin acetate | IMPLANT;SUBCUTANEOUS | 022058-001 | May 3, 2007 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| Endo Pharm | SUPPRELIN LA | histrelin acetate | IMPLANT;SUBCUTANEOUS | 022058-001 | May 3, 2007 | ⤷ Free Forever Trial | ⤷ Free Forever Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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