Details for New Drug Application (NDA): 022074
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NDA 022074 describes SOMATULINE DEPOT, which is a drug marketed by Ipsen Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the SOMATULINE DEPOT profile page.
The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.
The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.
Summary for 022074
| Tradename: | SOMATULINE DEPOT |
| Applicant: | Ipsen Pharma |
| Ingredient: | lanreotide acetate |
| Patents: | 0 |
Pharmacology for NDA: 022074
| Mechanism of Action | Somatostatin Receptor Agonists |
Suppliers and Packaging for NDA: 022074
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-1060 | 15054-1060-4 | 1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE |
| SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-1090 | 15054-1090-4 | 1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | ||||
| Approval Date: | Aug 30, 2007 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 15, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | ||||
| Approval Date: | Aug 30, 2007 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 15, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | ||||
| Approval Date: | Aug 30, 2007 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 15, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY | ||||||||
Expired US Patents for NDA 022074
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-001 | Aug 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-003 | Aug 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| Ipsen Pharma | SOMATULINE DEPOT | lanreotide acetate | SOLUTION;SUBCUTANEOUS | 022074-002 | Aug 30, 2007 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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