DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 200122
NDA 200122 describes TERBUTALINE SULFATE, which is a drug marketed by Akorn, Athenex Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Teva Pharms Usa, United Biomedcl, Impax Labs, and Lannett, and is included in eight NDAs. It is available from fifteen suppliers. Additional details are available on the TERBUTALINE SULFATE profile page.
The generic ingredient in TERBUTALINE SULFATE is terbutaline sulfate. There are seven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
The generic ingredient in TERBUTALINE SULFATE is terbutaline sulfate. There are seven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 200122
| Tradename: | TERBUTALINE SULFATE |
| Applicant: | United Biomedcl |
| Ingredient: | terbutaline sulfate |
| Patents: | 0 |
| Therapeutic Class: | Respiratory Tract Agents |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 200122
Suppliers and Packaging for NDA: 200122
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 200122 | ANDA | United Biomedical Inc., Asia | 10271-101 | N | 10271-101-10 |
| TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 200122 | ANDA | Athenex Pharmaceutical Division, LLC. | 70860-801 | N | 70860-801-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Nov 8, 2013 | TE: | AP | RLD: | No | ||||
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