Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087165
Company: COSETTE PHARMS NC
Company: COSETTE PHARMS NC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | 50MG | SUPPOSITORY;RECTAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 08/14/1987 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/087165ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/07/2016 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/30/2012 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/30/2012 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/16/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/16/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/04/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/23/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |