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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016093
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EDECRIN ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
01/10/1967 ORIG-1 Approval Type 2 - New Active Ingredient 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
07/20/2005 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/2005 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16092s042,16093s044ltr.pdf
02/03/2004 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16092slr039,16093slr043ltr.pdf
06/10/2002 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/19/2001 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2001 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/2001 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1999 SUPPL-38 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/16092s037_Edecrin.pdf
09/03/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/03/1997 SUPPL-36 Labeling

Label is not available on this site.

11/30/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

03/24/1995 SUPPL-34 Labeling

Label is not available on this site.

10/08/1996 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/30/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/08/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/21/1986 SUPPL-29 Labeling

Label is not available on this site.

01/13/1986 SUPPL-28 Labeling

Label is not available on this site.

08/27/1985 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/11/1984 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/28/1984 SUPPL-25 Labeling

Label is not available on this site.

09/20/1983 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1981 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 SUPPL-20 Labeling

Label is not available on this site.

08/28/1981 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/16/1981 SUPPL-18 Labeling

Label is not available on this site.

02/19/1981 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/25/1980 SUPPL-16 Labeling

Label is not available on this site.

06/21/1979 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1978 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1978 SUPPL-13 Labeling

Label is not available on this site.

01/29/1976 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2005 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf

EDECRIN

INJECTABLE;INJECTION; EQ 50MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EDECRIN ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 016093 BAUSCH
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204634 MYLAN INSTITUTIONAL
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205473 PAR STERILE PRODUCTS
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 208663 VPI PHARMS INC
ETHACRYNATE SODIUM ETHACRYNATE SODIUM EQ 50MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207758 ZYDUS PHARMS
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