Details for New Drug Application (NDA): 210317
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NDA 210317 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 210317
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210317
Suppliers and Packaging for NDA: 210317
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 210317 | ANDA | Teva Pharmaceuticals, Inc. | 0480-9257 | 0480-9257-08 | 1 KIT in 1 KIT (0480-9257-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9256-01) * 2 mL in 1 SYRINGE (0480-9263-21) |
| OCTREOTIDE ACETATE | octreotide acetate | INJECTABLE;INJECTION | 210317 | ANDA | Teva Pharmaceuticals, Inc. | 0480-9259 | 0480-9259-08 | 1 KIT in 1 KIT (0480-9259-08) * 8 mL in 1 VIAL, SINGLE-DOSE (0480-9258-01) * 2 mL in 1 SYRINGE (0480-9263-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/VIAL | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 30MG BASE/VIAL | ||||
| Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No | ||||
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