Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062124
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription AT No 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
09/23/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/19/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/07/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/25/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/06/1994 SUPPL-4 Labeling

Label is not available on this site.

06/03/1993 SUPPL-3 Labeling

Label is not available on this site.

03/11/1994 SUPPL-2 Labeling

Label is not available on this site.

03/11/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

NYSTATIN

OINTMENT;TOPICAL; 100,000 UNITS/GM
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209114 ACP NIMBLE
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 062840 ACTAVIS MID ATLANTIC
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 207767 CADILA
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 062124 FOUGERA PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 209082 LYNE
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 062472 PERRIGO NEW YORK
NYSTATIN NYSTATIN 100,000 UNITS/GM OINTMENT;TOPICAL Prescription No AT 211838 TORRENT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English