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
BRETHINE از شرکت ANI PHARMS
New Drug Application (NDA): 017849
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETHINE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| BRETHINE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1976 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 04/08/2011 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2003 | SUPPL-39 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17849slr039,18571slr019ltr.pdf |
|
| 03/04/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/2002 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/08/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 02/25/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1995 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/14/1995 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/24/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1992 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1993 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/22/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/1981 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1980 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/25/1980 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/04/1980 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1979 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/03/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1979 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/03/1979 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/03/1979 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/08/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1977 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
BRETHINE
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRETHINE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | Yes | AB | 017849 | ANI PHARMS |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 075877 | IMPAX LABS |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 077152 | LANNETT CO INC |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 2.5MG | TABLET;ORAL | Prescription | No | AB | 211832 | TWI PHARMS |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRETHINE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 017849 | ANI PHARMS |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075877 | IMPAX LABS |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077152 | LANNETT CO INC |
| TERBUTALINE SULFATE | TERBUTALINE SULFATE | 5MG | TABLET;ORAL | Prescription | No | AB | 211832 | TWI PHARMS |
نظرات کاربران