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
BETIMOL از شرکت AKORN
New Drug Application (NDA): 020439
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETIMOL | TIMOLOL | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
Yes | Yes |
| BETIMOL | TIMOLOL | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 03/31/1995 | ORIG-1 | Approval |
Type 2 – New Active Ingredient |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/21/2004 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20439s011ltr.pdf |
||
| 02/08/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/08/1999 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/04/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/21/2004 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20439s011lbl.pdf |
BETIMOL
SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETIMOL | TIMOLOL | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020439 | AKORN |
| TIMOLOL | TIMOLOL | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205309 | AKORN |
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETIMOL | TIMOLOL | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020439 | AKORN |
| TIMOLOL | TIMOLOL | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 205309 | AKORN |
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