Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074941
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/15/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/13/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/15/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-941_Diltiazem_prntlbl.pdf |
DILTIAZEM HYDROCHLORIDE
INJECTABLE;INJECTION; 5MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216552 | EUGIA PHARMA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078538 | HIKMA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074941 | HOSPIRA |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075086 | RISING |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 5MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074617 | SAGENT |