Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200465
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;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 |
|---|---|---|---|---|---|---|---|
| 11/29/2013 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200465Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/06/2022 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/06/2019 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 11/16/2015 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
TABLET;ORAL; EQ 5MG BASE;EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 5MG BASE;EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 5MG BASE;EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 5MG BASE;EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 5MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 10MG BASE;EQ 10MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 10MG BASE;EQ 20MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 10MG BASE;EQ 40MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 10MG BASE;EQ 80MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 205199 | APOTEX |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 200465 | MYLAN |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | ZYDUS PHARMS |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |