Details for New Drug Application (NDA): 075957
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NDA 075957 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 075957
| Tradename: | OCTREOTIDE ACETATE |
| Applicant: | Meitheal |
| Ingredient: | octreotide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075957
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Oct 3, 2005 | 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: | Oct 3, 2005 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 0.5MG BASE/ML | ||||
| Approval Date: | Oct 3, 2005 | TE: | AP | RLD: | No | ||||
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