Details for New Drug Application (NDA): 077457
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NDA 077457 describes OCTREOTIDE ACETATE (PRESERVATIVE FREE), which is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Sagent Pharms Inc, and West-ward Pharms Int, and is included in four NDAs. It is available from four suppliers. Additional details are available on the OCTREOTIDE ACETATE (PRESERVATIVE FREE) profile page.
The generic ingredient in OCTREOTIDE ACETATE (PRESERVATIVE FREE) is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
The generic ingredient in OCTREOTIDE ACETATE (PRESERVATIVE FREE) is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 077457
| Tradename: | OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Pharmacology for NDA: 077457
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 077457
Suppliers and Packaging for NDA: 077457
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 077457 | ANDA | Fresenius Kabi USA, LLC | 63323-376 | 63323-376-01 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-00) |
| OCTREOTIDE ACETATE (PRESERVATIVE FREE) | octreotide acetate | INJECTABLE;INJECTION | 077457 | ANDA | Fresenius Kabi USA, LLC | 63323-376 | 63323-376-04 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-376-04) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-376-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Feb 10, 2006 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.1MG BASE/ML | ||||
| Approval Date: | Feb 10, 2006 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/ML | ||||
| Approval Date: | Feb 10, 2006 | TE: | AP | RLD: | No | ||||
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