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
CASPORYN HC از شرکت CASPER PHARMA LLC
New Drug Application (NDA): 060613
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CASPORYN HC | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription |
AT |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/25/1975 | 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 |
|---|---|---|---|---|---|
| 12/19/2017 | SUPPL-13 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060613s013lbl.pdf |
||
| 07/23/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/10/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/14/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/04/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/19/2017 | SUPPL-13 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/060613s013lbl.pdf |
CASPORYN HC
SUSPENSION/DROPS;OTIC; 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CASPORYN HC | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | Yes | AT | 060613 | CASPER PHARMA LLC |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 065219 | AMRING PHARMS |
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 062488 | SANDOZ INC |
| OTICAIR | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OTIC | Prescription | No | AT | 064065 | BAUSCH AND LOMB |
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