Details for New Drug Application (NDA): 203765
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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 203765
Tradename: | OCTREOTIDE ACETATE |
Applicant: | Heritage Pharms |
Ingredient: | octreotide acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203765
Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 203765
Suppliers and Packaging for NDA: 203765
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 203765 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-685 | 23155-685-31 | 5 mL in 1 VIAL, GLASS (23155-685-31) |
OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 203765 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-686 | 23155-686-31 | 5 mL in 1 VIAL, GLASS (23155-686-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.2MG BASE/ML | ||||
Approval Date: | Sep 7, 2018 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
Approval Date: | Sep 7, 2018 | TE: | AP | RLD: | No |
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