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
ALBUTEROL SULFATE از شرکت SUN PHARM INDUSTRIES
Abbreviated New Drug Application (ANDA): 072637
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/01/1989 | 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 |
|---|---|---|---|---|---|
| 12/11/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/05/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/04/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/29/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/22/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
ALBUTEROL SULFATE
TABLET;ORAL; EQ 4MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 210948 | AIZANT |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208804 | AMNEAL PHARMS CO |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 072894 | MYLAN |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 207046 | RISING |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 072637 | SUN PHARM INDUSTRIES |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 211397 | VIRTUS PHARM |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 4MG BASE | TABLET;ORAL | Prescription | No | AB | 208884 | ZYDUS PHARMS |
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 210948 | AIZANT |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208804 | AMNEAL PHARMS CO |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 072894 | MYLAN |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 207046 | RISING |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 072637 | SUN PHARM INDUSTRIES |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 211397 | VIRTUS PHARM |
| ALBUTEROL SULFATE | ALBUTEROL SULFATE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 208884 | ZYDUS PHARMS |
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