Serving 500+ biopharmaceutical companies globally:
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Serving 500+ biopharmaceutical companies globally:
Generated: September 24, 2017
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
ORKAMBI |
ivacaftor; lumacaftor |
TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-700 | 51167-700-02 | 4 CARTON in 1 BOX (51167-700-02) > 7 BLISTER PACK in 1 CARTON > 4 TABLET, FILM COATED in 1 BLISTER PACK |
ORKAMBI |
ivacaftor; lumacaftor |
TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-809 | 51167-809-01 | 4 CARTON in 1 BOX (51167-809-01) > 7 BLISTER PACK in 1 CARTON > 4 TABLET, FILM COATED in 1 BLISTER PACK |
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG;200MG | ||||
| Approval Date: | Jul 2, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 2, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 2, 2022 | ||||||||
| Regulatory Exclusivity Use: | ORPHAN DRUG EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 28, 2023 | ||||||||
| Regulatory Exclusivity Use: | ORPHAN DRUG EXCLUSIVITY | ||||||||
Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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