Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077686
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/15/2010 | 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 |
|---|---|---|---|---|---|
| 04/09/2026 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2024 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2016 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/21/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
DILTIAZEM HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 420MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 360MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 240MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 180MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |
TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021392 | BAUSCH |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077686 | ACTAVIS LABS FL INC |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216439 | AMTA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216327 | SCIEGEN PHARMS |