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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050299
Company: CHARTWELL MOLECULES

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NILSTAT NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription AA 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
04/14/1971 ORIG-1 Approval UNKNOWN

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
05/18/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
07/28/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
07/28/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
02/16/1995 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/01/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
02/05/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
09/25/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
09/21/1978 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
01/11/1977 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.
12/23/1974 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.
07/22/1974 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
02/15/1974 SUPPL-9 Labeling

Label is not available on this site.
02/11/1974 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
02/22/1974 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/17/1972 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/28/1972 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
07/25/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
07/02/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
10/14/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
07/13/1983 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

NILSTAT

SUSPENSION;ORAL; 100,000 UNITS/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NILSTAT NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription Yes AA 050299 CHARTWELL MOLECULES
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062517 FOUGERA PHARMS INC
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 065148 GENUS
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 203621 PHARM ASSOC
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062512 PHARMOBEDIENT
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 062832 SCIEGEN PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 214346 SENORES PHARMS
NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION;ORAL Prescription No AA 220367 STERANCO HLTHCARE
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