Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021231
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOMIG-ZMT ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
ZOMIG-ZMT ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/13/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21231ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2018 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020768Orig1s023,021231Orig1s014,021450Orig1s010Ltr.pdf
09/14/2012 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
09/14/2012 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf
08/11/2010 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021231s009ltr.pdf
01/08/2004 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf
05/21/2003 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf
10/09/2002 SUPPL-3 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021231_S003_ZOMIG_TABLETS.pdf
12/04/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/17/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/21/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020768s023,021231s014,021450s010lbl.pdf
09/14/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
09/14/2012 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf
08/11/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf
02/13/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf

ZOMIG-ZMT

TABLET, ORALLY DISINTEGRATING;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205074 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202560 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202956 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204336 MACLEODS PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202890 ZYDUS PHARMS USA INC
ZOMIG-ZMT ZOLMITRIPTAN 2.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021231 ASTRAZENECA

TABLET, ORALLY DISINTEGRATING;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205074 ALEMBIC PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202560 GLENMARK GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202956 JUBILANT GENERICS
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 204336 MACLEODS PHARMS LTD
ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202890 ZYDUS PHARMS USA INC
ZOMIG-ZMT ZOLMITRIPTAN 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021231 ASTRAZENECA

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