Details for New Drug Application (NDA): 216807
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NDA 216807 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Heritage, Meitheal, Sagent Pharms Inc, Shuangcheng, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, and Mylan Institutional, and is included in twenty-two NDAs. It is available from seven suppliers. Additional details are available on the OCTREOTIDE ACETATE profile page.
The generic ingredient in OCTREOTIDE ACETATE 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 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 216807
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Pharmacology for NDA: 216807
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216807
Suppliers and Packaging for NDA: 216807
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216807 | ANDA | Gland Pharma Limited | 68083-515 | 68083-515-01 | 1 VIAL in 1 CARTON (68083-515-01) / 5 mL in 1 VIAL |
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216807 | ANDA | Gland Pharma Limited | 68083-516 | 68083-516-01 | 1 VIAL in 1 CARTON (68083-516-01) / 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: | Jun 13, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1MG BASE/ML | ||||
| Approval Date: | Jun 13, 2023 | TE: | AP | RLD: | No | ||||
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