Details for New Drug Application (NDA): 200122
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NDA 200122 describes TERBUTALINE SULFATE, which is a drug marketed by Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in nine NDAs. It is available from eleven 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 200122
| Tradename: | TERBUTALINE SULFATE |
| Applicant: | Areva Pharms |
| Ingredient: | terbutaline sulfate |
| Patents: | 0 |
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 | Areva Pharmaceuticals | 59923-615 | 59923-615-05 | 5 VIAL, SINGLE-USE in 1 CARTON (59923-615-05) / 1 mL in 1 VIAL, SINGLE-USE (59923-615-01) |
| TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 200122 | ANDA | Medical Purchasing Solutions, LLC | 71872-7130 | 71872-7130-1 | 1 VIAL in 1 BAG (71872-7130-1) / 1 mL in 1 VIAL |
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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