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ZOLMITRIPTAN

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Zomig (zolmitriptan) Nasal Spray, AstraZeneca NDA 21-450 9/30/03 10/10/03 10/10/03 | Zomig (zolmitriptan) tablets, AstraZeneca LP NDA 20-768/S-006 1/29/02 3/6/02 | Zomig (zolmitriptan) tablets & Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, AstraZeneca LP NDA 20-768/S-010 & 21-231/S-03 10/9/02 10/21/02 | Zomig-ZMT (zolmitritpan) Orally Disintegrating Tablets, AstraZeneca NDA 21-231 2/13/01 3/30/01 3/30/01 | Zomig Indications: Acute treatment of Migraine. Zomig (zolmitriptan) nasal spray, AstraZeneca, Labeling Revision | Zomig (zolmitriptan) Tablets, AstraZeneca Pharma, Patient Population Altered | Zomig (zolmitriptan) Nasal Spray, AstraZeneca, Patient Population Altered | Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets, AstraZeneca Pharmaceuticals, Approval | Zomig (zolmitriptan) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision | Zolmitriptan Tablets, Teva Pharmaceuticals, Tentative Approval | Zolmitriptan Tablets, Glenmark Generics Limited, Tentative Approval | Zomig, zolmitriptan, Tablet; Oral, Ipr, Labeling Revision | Zomig-Zmt, zolmitriptan, Tablet, Orally Disintegrating; Oral, Astrazeneca, Labeling Revision | Zolmitriptan, zolmitriptan, Tablet, Orally Disintegrating; Oral, Zydus Pharms Usa Inc, Approval | Zolmitriptan, zolmitriptan, Tablet; Oral, Glenmark Generics, Approval | Zolmitriptan, zolmitriptan, Tablet; Oral, Apotex Inc, Approval | Zolmitriptan, zolmitriptan, Tablet, Orally Disintegrating; Oral, Apotex Inc, Approval | Zolmitriptan, zolmitriptan, Tablet, Orally Disintegrating; Oral, Glenmark Generics, Approval | Zolmitriptan, zolmitriptan, Tablet; Oral, Mylan Pharms Inc, Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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