Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050536
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERYC | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/23/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050536s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050536Orig1s026ltr.pdf | |
| 12/19/2013 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050536s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050536s022ltr.pdf | |
| 03/21/2013 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050536s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050536Orig1s021ltr_corrected.pdf |
| 02/21/2008 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050536s020ltr.pdf | |
| 01/12/2006 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050536s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050536s019ltr.pdf | |
| 12/18/2003 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50536slr018ltr.pdf |
| 02/02/2004 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50536slr016ltr.pdf |
| 08/05/1999 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/30/1982 | SUPPL-12 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/28/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1981 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/15/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/05/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1986 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/05/1981 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/20/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/22/1981 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/23/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050536s026lbl.pdf | |
| 03/21/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050536s021lbl.pdf |
| 02/14/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050536s022lbl.pdf | |
| 02/21/2008 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf | |
| 01/12/2006 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050536s019lbl.pdf |
ERYC
CAPSULE, DELAYED REL PELLETS;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ERYC | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | Yes | AB | 050536 | DR REDDYS LABS SA |
| ERYTHROMYCIN | ERYTHROMYCIN | 250MG | CAPSULE, DELAYED REL PELLETS;ORAL | Prescription | No | AB | 062746 | AZURITY |