Drugs@FDA: FDA-Approved Drugs
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 | STERIMAX |
| ETHACRYNATE SODIUM | ETHACRYNATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 207758 | ZYDUS PHARMS |