Details for New Drug Application (NDA): 216839
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NDA 216839 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Gland, 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 nine 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.
Summary for 216839
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Gland |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Pharmacology for NDA: 216839
| Mechanism of Action | Somatostatin Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216839
Suppliers and Packaging for NDA: 216839
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216839 | ANDA | Gland Pharma Limited | 68083-517 | 68083-517-10 | 10 VIAL in 1 CARTON (68083-517-10) / 1 mL in 1 VIAL |
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216839 | ANDA | Gland Pharma Limited | 68083-560 | 68083-560-10 | 10 VIAL in 1 CARTON (68083-560-10) / 1 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/ML | ||||
| Approval Date: | Jun 22, 2023 | 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: | Jun 22, 2023 | TE: | AP | RLD: | No | ||||
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