Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075172
Company: CHARTWELL
Company: CHARTWELL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COLOCORT | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | 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 |
---|---|---|---|---|---|---|---|
12/03/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75172ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/23/2008 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
07/27/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
05/08/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
COLOCORT
ENEMA;RECTAL; 100MG/60ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COLOCORT | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | Prescription | No | AB | 075172 | CHARTWELL |
CORTENEMA | HYDROCORTISONE | 100MG/60ML | ENEMA;RECTAL | Prescription | Yes | AB | 016199 | ANI PHARMS |