Details for New Drug Application (NDA): 078630
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NDA 078630 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 078630
| Tradename: | TERBUTALINE SULFATE |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | terbutaline sulfate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 078630
Suppliers and Packaging for NDA: 078630
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 078630 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9375 | 0143-9375-10 | 10 VIAL in 1 CARTON (0143-9375-10) / 1 mL in 1 VIAL (0143-9375-01) |
| TERBUTALINE SULFATE | terbutaline sulfate | INJECTABLE;INJECTION | 078630 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9746 | 0143-9746-10 | 10 VIAL in 1 CARTON (0143-9746-10) / 1 mL in 1 VIAL (0143-9746-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | May 20, 2009 | TE: | AP | RLD: | No | ||||
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