Details for New Drug Application (NDA): 216589
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NDA 216589 describes OCTREOTIDE ACETATE, which is a drug marketed by Fresenius Kabi Usa, Gland, Heritage, Meitheal, Mylan Labs Ltd, 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-three NDAs. It is available from ten 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 216589
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 216589
Suppliers and Packaging for NDA: 216589
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216589 | ANDA | Mylan Institutional LLC | 67457-756 | 67457-756-10 | 1 KIT in 1 KIT (67457-756-10) * 6 mL in 1 VIAL (67457-754-10) * 2 mL in 1 SYRINGE (67457-755-02) |
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 216589 | ANDA | Mylan Institutional LLC | 67457-759 | 67457-759-20 | 1 KIT in 1 KIT (67457-759-20) * 6 mL in 1 VIAL (67457-757-20) * 2 mL in 1 SYRINGE (67457-758-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/VIAL | ||||
| Approval Date: | Dec 12, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Aug 2, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Dec 12, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 27, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/VIAL | ||||
| Approval Date: | Dec 12, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jul 27, 2026 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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