Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076563
Company: NESHER PHARMS
Company: NESHER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 420MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76563ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/15/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/25/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |