Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075951
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 05/25/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75951_Norethindrone Acetate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75951ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075951_norethindrone_acetate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/31/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/12/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/14/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/26/2001 | 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 |
|---|---|---|---|---|---|
| 05/25/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75951_Norethindrone Acetate_Prntlbl.pdf |
NORETHINDRONE ACETATE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 200275 | AMNEAL PHARMS |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 075951 | BARR |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 091090 | GLENMARK PHARMS LTD |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 205278 | MYLAN LABS LTD |
| NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET;ORAL | Prescription | No | AB | 206490 | NOVAST LABS |