Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216439
Company: AMTA
Company: AMTA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | 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 | 240MG | 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 | 360MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DILTIAZEM HYDROCHLORIDE
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 INC |
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 INC |
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 INC |
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 INC |
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 INC |
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 INC |