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Details for New Drug Application (NDA): 019667
The generic ingredient in SANDOSTATIN is octreotide acetate. There are nineteen drug master file entries for this compound. Nine 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 |
Therapeutic Class: | Hormonal Agents, Suppressant (Pituitary) |
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 | N | 0078-0180-01 |
SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667 | NDA | Novartis Pharmaceuticals Corporation | 0078-0181 | N | 0078-0181-01 |
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 | 019667-003 | Oct 21, 1988 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-004 | Jun 12, 1991 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Novartis | SANDOSTATIN | octreotide acetate | INJECTABLE;INJECTION | 019667-002 | Oct 21, 1988 | ➤ Try a Free Trial | ➤ Try a Free Trial |
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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