Drugs@FDA: FDA-Approved Drugs
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | AB | No | No |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
11/27/1978 | 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 |
---|---|---|---|---|---|
11/02/2018 | SUPPL-35 | Manufacturing (CMC)-New Strength |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/062055Orig1s035.pdf |
11/02/2018 | SUPPL-34 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/062055Orig1s034.pdf |
04/25/2014 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
06/01/2001 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
05/24/2001 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/2001 | SUPPL-29 | Labeling |
Label is not available on this site. |
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12/21/1999 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/20/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/08/1998 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
12/01/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/25/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/22/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/23/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/11/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
04/03/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/25/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
04/29/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
E.E.S. | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 211204 | AMNEAL PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 216212 | CADILA PHARMS LTD |
GRANULE;ORAL; EQ 400MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 211204 | AMNEAL PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 400MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 216212 | CADILA PHARMS LTD |
GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
E.E.S. | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYPED | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | Yes | AB | 050207 | AZURITY |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 211204 | AMNEAL PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 062055 | ANI PHARMS |
ERYTHROMYCIN ETHYLSUCCINATE | ERYTHROMYCIN ETHYLSUCCINATE | EQ 200MG BASE/5ML | GRANULE;ORAL | Prescription | No | AB | 216212 | CADILA PHARMS LTD |