Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209288
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG 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 |
|---|---|---|---|---|---|---|---|
| 12/21/2018 | ORIG-1 | Approval | 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 |
|---|---|---|---|---|---|
| 06/09/2023 | SUPPL-14 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2023 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/03/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/03/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ATORVASTATIN CALCIUM
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217634 | ACI |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 090548 | APOTEX INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091650 | DR REDDYS LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 204991 | LUPIN LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091226 | MYLAN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | SANDOZ INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 076477 | SUN PHARM INDS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205300 | TEVA PHARMS USA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 213853 | UMEDICA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 217634 | ACI |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 090548 | APOTEX INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091650 | DR REDDYS LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 204991 | LUPIN LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091226 | MYLAN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | SANDOZ INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 076477 | SUN PHARM INDS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205300 | TEVA PHARMS USA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 213853 | UMEDICA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 217634 | ACI |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 090548 | APOTEX INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 091650 | DR REDDYS LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 204991 | LUPIN LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 091226 | MYLAN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | SANDOZ INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 076477 | SUN PHARM INDS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205300 | TEVA PHARMS USA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 213853 | UMEDICA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |
TABLET;ORAL; EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 207687 | ACCORD HLTHCARE |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 217634 | ACI |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214969 | AGNITIO |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 209288 | ALKEM LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 090548 | APOTEX INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 217118 | AUROBINDO PHARMA LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 216436 | BIOCON PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214659 | DR REDDYS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 202357 | DR REDDYS LABS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 209912 | GRAVITI PHARMS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214344 | HETERO LABS LTD V |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 091624 | LANNETT CO INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 214513 | LAURUS |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 204991 | LUPIN LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 217081 | MANKIND PHARMA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205945 | MICRO LABS LTD INDIA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 211933 | MSN |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 091226 | MYLAN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 077575 | SANDOZ INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205519 | SCIEGEN PHARMS INC |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 211886 | SHANDONG XINHUA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 076477 | SUN PHARM INDS LTD |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205300 | TEVA PHARMS USA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 213853 | UMEDICA |
| ATORVASTATIN CALCIUM | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 206536 | ZYDUS PHARMS |
| LIPITOR | ATORVASTATIN CALCIUM | EQ 80MG BASE | TABLET;ORAL | Prescription | Yes | AB | 020702 | UPJOHN |