Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074769
Company: RHODES PHARMS
Company: RHODES PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/02/1998 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74769ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-29 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-28 | REMS-Modified |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-27 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-24 | REMS-Modified |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-22 | REMS-Proposal |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-20 | REMS-Modified |
Label is not available on this site. |
||
| 07/21/2014 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
||
| 09/28/2012 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/09/2012 | SUPPL-10 | REMS-Proposal |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/11/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/02/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf |
MORPHINE SULFATE
TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074769 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076438 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |
TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203849 | ACTAVIS ELIZABETH |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203602 | NOVEL LABS INC |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 074769 | RHODES PHARMS |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076438 | SPECGX LLC |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075295 | STRIDES PHARMA |
| MORPHINE SULFATE | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078761 | SUN PHARM INDS LTD |
| MS CONTIN | MORPHINE SULFATE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 019516 | PURDUE PHARMA LP |