اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHLOROPTIC از شرکت ALLERGAN
New Drug Application (NDA): 050091
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROPTIC | CHLORAMPHENICOL | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 03/20/1968 | 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 |
|---|---|---|---|---|---|
| 04/12/2002 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/2001 | SUPPL-40 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf |
||
| 10/02/2000 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1997 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/26/1980 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1979 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1979 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1979 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/1977 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/15/1977 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/28/1976 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/13/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/20/1976 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1976 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/03/1976 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/21/1975 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1975 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 11/26/1974 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/14/1974 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1974 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/20/1974 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/18/1974 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/22/1971 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/11/1972 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/03/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/05/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1969 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/30/2001 | SUPPL-40 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50091s40lbl.pdf |
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