Details for New Drug Application (NDA): 091041
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The generic ingredient in OCTREOTIDE ACETATE is octreotide acetate. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 091041
Tradename: | OCTREOTIDE ACETATE |
Applicant: | Sagent Pharms Inc |
Ingredient: | octreotide acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091041
Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 091041
Suppliers and Packaging for NDA: 091041
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 091041 | ANDA | Sagent Pharmaceuticals | 25021-466 | 25021-466-05 | 1 VIAL in 1 CARTON (25021-466-05) / 5 mL in 1 VIAL |
OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 091041 | ANDA | Sagent Pharmaceuticals | 25021-467 | 25021-467-05 | 1 VIAL in 1 CARTON (25021-467-05) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.2MG BASE/ML | ||||
Approval Date: | Nov 12, 2013 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Nov 12, 2013 | TE: | AP | RLD: | No |
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