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Details for New Drug Application (NDA): 019667
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NDA 019667 describes SANDOSTATIN, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the SANDOSTATIN profile page.
The generic ingredient in SANDOSTATIN is octreotide acetate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
The generic ingredient in SANDOSTATIN is octreotide acetate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 019667
| Tradename: | SANDOSTATIN |
| Applicant: | Novartis |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019667
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019667
Suppliers and Packaging for NDA: 019667
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667 | NDA | Novartis Pharmaceuticals Corporation | 0078-0180 | 0078-0180-01 | 10 AMPULE in 1 PACKAGE (0078-0180-01) > 1 mL in 1 AMPULE (0078-0180-61) |
| SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667 | NDA | Novartis Pharmaceuticals Corporation | 0078-0181 | 0078-0181-01 | 10 AMPULE in 1 PACKAGE (0078-0181-01) > 1 mL in 1 AMPULE (0078-0181-61) |
Paragraph IV (Patent) Challenges for 019667
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SANDOSTATIN | INJECTABLE;INJECTION | octreotide acetate | 019667 | 2008-01-17 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Oct 21, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/ML | ||||
| Approval Date: | Oct 21, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/ML | ||||
| Approval Date: | Oct 21, 1988 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 019667
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-001 | Oct 21, 1988 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-003 | Oct 21, 1988 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-005 | Jun 12, 1991 | Start Trial | Start Trial |
| Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-003 | Oct 21, 1988 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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