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
ALENDRONATE SODIUM از شرکت IMPAX LABS INC
Abbreviated New Drug Application (ANDA): 075710
Company: IMPAX LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG 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 |
|---|---|---|---|---|---|---|---|
| 02/06/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/22/2012 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2013 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/01/2011 | SUPPL-8 | Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/22/2010 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 10/20/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
ALENDRONATE SODIUM
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 077982 | APOTEX |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090258 | HANGZHOU BINJIANG |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 075710 | IMPAX LABS INC |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 090022 | SUN PHARM |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077982 | APOTEX |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090124 | AUROBINDO PHARMA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090258 | HANGZHOU BINJIANG |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 075710 | IMPAX LABS INC |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090022 | SUN PHARM |
TABLET;ORAL; EQ 35MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 077982 | APOTEX |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 090124 | AUROBINDO PHARMA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 090258 | HANGZHOU BINJIANG |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 075710 | IMPAX LABS INC |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 090022 | SUN PHARM |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Prescription | No | AB | 076984 | WATSON LABS |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 075710 | IMPAX LABS INC |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076984 | WATSON LABS |
TABLET;ORAL; EQ 70MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 077982 | APOTEX |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090124 | AUROBINDO PHARMA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 076768 | CIPLA |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090258 | HANGZHOU BINJIANG |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 075710 | IMPAX LABS INC |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 090022 | SUN PHARM |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | No | AB | 076984 | WATSON LABS |
| FOSAMAX | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020560 | MERCK AND CO INC |
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