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Generated: June 29, 2017

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Details for New Drug Application (NDA): 201993

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NDA 201993 describes RIZATRIPTAN BENZOATE, which is a drug marketed by Glenmark Pharms Ltd, Panacea Biotec Ltd, Cipla Ltd, Sandoz, Jubilant Generics, Unichem Labs Ltd, Invagen Pharms, Apotex Inc, Macleods Pharms Ltd, Eci Pharms Llc, Aurobindo Pharma Ltd, Teva Pharms, Glenmark Generics, Alkem Labs Ltd, Mylan Pharms Inc, Natco Pharma Ltd, and Emcure Pharms Ltd, and is included in twenty-five NDAs. It is available from twenty-four suppliers. Additional details are available on the RIZATRIPTAN BENZOATE profile page.

The generic ingredient in RIZATRIPTAN BENZOATE is rizatriptan benzoate. There are twenty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the rizatriptan benzoate profile page.

Summary for NDA: 201993

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antimigraine Agents

Pharmacology for NDA: 201993

Suppliers and Packaging for NDA: 201993

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIZATRIPTAN BENZOATE
rizatriptan benzoate
TABLET;ORAL 201993 ANDA Mylan Pharmaceuticals Inc. 0378-1403 0378-1403-96 12 TABLET in 1 BOTTLE, PLASTIC (0378-1403-96)
RIZATRIPTAN BENZOATE
rizatriptan benzoate
TABLET;ORAL 201993 ANDA Mylan Pharmaceuticals Inc. 0378-1404 0378-1404-96 12 TABLET in 1 BOTTLE, PLASTIC (0378-1404-96)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Dec 31, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 31, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
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Julphar
Queensland Health
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Argus Health
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Mallinckrodt
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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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