Details for New Drug Application (NDA): 091041
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NDA 091041 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 091041
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Sagent Pharms Inc |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
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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