Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DOPRAM | DOXAPRAM HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/23/1965 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/17/2005 | SUPPL-44 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14879s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/014879_S044_Dopram Injection_APPROVAL_ PACKAGE.pdf | |
| 04/16/2004 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/14879slr040ltr.pdf | |
| 03/29/2006 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014879s037ltr.pdf |
| 08/23/2001 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/14879s36ltr.pdf |
| 02/13/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1989 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/31/1988 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1987 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/14/1987 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/18/1986 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/24/1986 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/02/1983 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 03/04/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-22 | Unspecified |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/06/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1978 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/27/1978 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/15/1979 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1977 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1977 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1976 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1979 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/17/2005 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14879s044lbl.pdf | |
| 04/16/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/14879slr040_dopram_lbl.pdf |
DOPRAM
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DOPRAM | DOXAPRAM HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 014879 | HIKMA |
| DOXAPRAM HYDROCHLORIDE | DOXAPRAM HYDROCHLORIDE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076266 | CHARTWELL INJECTABLE |