Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217279
Company: ALEMBIC
Company: ALEMBIC
| 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 | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 05/22/2025 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
TABLET;ORAL; EQ 2.5MG 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 2.5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 217279 | ALEMBIC |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | NEOCUBES PHARMA |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 2.5MG 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 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 217279 | ALEMBIC |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | NEOCUBES PHARMA |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
TABLET;ORAL; EQ 2.5MG 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 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 217279 | ALEMBIC |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 203874 | DR REDDYS |
| AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 207762 | NEOCUBES PHARMA |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 2.5MG BASE;EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |
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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| 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 | 217279 | ALEMBIC |
| 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 | NEOCUBES PHARMA |
| CADUET | AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM | EQ 10MG BASE;EQ 80MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021540 | PHARMACIA |