Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 016092
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EDECRIN ETHACRYNIC ACID 25MG TABLET;ORAL Prescription AB Yes Yes
EDECRIN ETHACRYNIC ACID 50MG TABLET;ORAL Discontinued None No 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
01/10/1967 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
03/30/2015 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/09/2005 SUPPL-42 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-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16092slr039,16093slr043ltr.pdf
08/14/1998 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1999 SUPPL-37 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/16092s037_Edecrin.pdf
11/03/1997 SUPPL-36 Labeling

Label is not available on this site.

06/24/1996 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1995 SUPPL-34 Labeling

Label is not available on this site.

09/26/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

09/06/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

08/15/1988 SUPPL-30 Manufacturing (CMC)-Control

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.

08/28/1984 SUPPL-27 Labeling

Label is not available on this site.

09/20/1983 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/19/1983 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1981 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/13/1985 SUPPL-23 Labeling

Label is not available on this site.

09/04/1981 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/16/1981 SUPPL-21 Labeling

Label is not available on this site.

02/19/1981 SUPPL-20 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/14/1980 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/22/1981 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/25/1980 SUPPL-17 Labeling

Label is not available on this site.

11/29/1979 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.

03/09/1979 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1978 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/1977 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1976 SUPPL-10 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-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/16092s042,16093s044lbl.pdf

EDECRIN

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EDECRIN ETHACRYNIC ACID 25MG TABLET;ORAL Prescription Yes AB 016092 BAUSCH
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211809 AGNITIO
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 205709 ALVOGEN
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 208805 AMNEAL PHARMS CO
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 205609 EDENBRIDGE PHARMS
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 207262 HIKMA
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211719 LUPIN LTD
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 208501 PAR PHARM INC
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 211232 SCIEGEN PHARMS INC
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 213240 STRIDES PHARMA
ETHACRYNIC ACID ETHACRYNIC ACID 25MG TABLET;ORAL Prescription No AB 212417 UPSHER SMITH LABS

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