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Details for New Drug Application (NDA): 204336

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NDA 204336 describes ZOLMITRIPTAN, which is a drug marketed by Aurobindo Pharma Ltd, Alembic Pharms Ltd, Macleods Pharms Ltd, Ajanta Pharma Ltd, Jubilant Generics, Glenmark Generics, Teva Pharms Usa, Pld Acquisitions Llc, Apotex Inc, Sun Pharma Global, Invagen Pharms, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the ZOLMITRIPTAN profile page.

The generic ingredient in ZOLMITRIPTAN is zolmitriptan. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.

Summary for NDA: 204336

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antimigraine Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204336

Suppliers and Packaging for NDA: 204336

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLMITRIPTAN
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL 204336 ANDA Macleods Pharmaceuticals Limited 33342-139 33342-139-10 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (33342-139-10)
ZOLMITRIPTAN
zolmitriptan
TABLET, ORALLY DISINTEGRATING;ORAL 204336 ANDA Macleods Pharmaceuticals Limited 33342-139 33342-139-12 10 BLISTER PACK in 1 CARTON (33342-139-12) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2.5MG
Approval Date:Oct 22, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Oct 22, 2015TE:ABRLD:No


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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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