DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 200122
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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