Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018751
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPECTAZOLE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1982 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2020 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018751Orig1s025ltr.pdf
09/07/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf
03/28/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf
07/11/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/17/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-11 Labeling

Label is not available on this site.

09/10/1992 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1990 SUPPL-6 Labeling

Label is not available on this site.

12/18/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/28/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/08/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/22/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/21/2020 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018751s025lbl.pdf
09/07/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018751s024lbl.pdf
03/28/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf

SPECTAZOLE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 076479 PERRIGO ISRAEL
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 076005 TARO
ECONAZOLE NITRATE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription No AB 076574 TELIGENT
SPECTAZOLE ECONAZOLE NITRATE 1% CREAM;TOPICAL Prescription Yes AB 018751 ALVOGEN

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