Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074845
Company: BIOVAIL
Company: BIOVAIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74845_Diltiazem_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74845ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-845_Diltiazem.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74845_Diltiazem_prntlbl.pdf |