Details for New Drug Application (NDA): 211832
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The generic ingredient in TERBUTALINE SULFATE is terbutaline sulfate. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 211832
Tradename: | TERBUTALINE SULFATE |
Applicant: | Twi Pharms |
Ingredient: | terbutaline sulfate |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 211832
Suppliers and Packaging for NDA: 211832
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 211832 | ANDA | TWi Pharmaceuticals, Inc. | 24979-132 | 24979-132-01 | 100 TABLET in 1 BOTTLE (24979-132-01) |
TERBUTALINE SULFATE | terbutaline sulfate | TABLET;ORAL | 211832 | ANDA | TWi Pharmaceuticals, Inc. | 24979-132 | 24979-132-03 | 1000 TABLET in 1 BOTTLE (24979-132-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jun 19, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jun 19, 2020 | TE: | AB | RLD: | No |
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