Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077982
Company: APOTEX
Company: APOTEX
| 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 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2008 | 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 |
|---|---|---|---|---|---|
| 03/16/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/26/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2014 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/30/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/23/2014 | SUPPL-2 | 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 | 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 | 206387 | IPCA LABS LTD |
| 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 | 206387 | IPCA LABS LTD |
| 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 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 | 206387 | IPCA LABS LTD |
| 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 | ORGANON |