Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077022
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | AB | No | No |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;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 |
---|---|---|---|---|---|---|---|
11/23/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77022ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/18/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
03/21/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/06/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
05/27/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
02/14/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/14/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
CILOSTAZOL
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077030 | APOTEX INC |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077831 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077022 | EPIC PHARMA LLC |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE RUN PHARMA |
CILOSTAZOL | CILOSTAZOL | 100MG | TABLET;ORAL | Prescription | No | AB | 077027 | TEVA |
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077030 | APOTEX INC |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077722 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077831 | CHARTWELL RX |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077022 | EPIC PHARMA LLC |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077208 | SLATE RUN PHARMA |
CILOSTAZOL | CILOSTAZOL | 50MG | TABLET;ORAL | Prescription | No | AB | 077027 | TEVA |