Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOR-QD | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 01/02/1973 | 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 |
|---|---|---|---|---|---|
| 12/03/2015 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/2015 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/2012 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/2005 | SUPPL-67 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017060s067ltr.pdf |
| 09/30/1999 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1999 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/1999 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 12/11/1996 | SUPPL-63 | Labeling |
Label is not available on this site. |
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| 05/23/1995 | SUPPL-62 | Labeling |
Label is not available on this site. |
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| 05/26/1995 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 09/19/1990 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/02/1990 | SUPPL-58 | Labeling |
Label is not available on this site. |
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| 10/22/1986 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 10/25/1985 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 06/19/1985 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 11/13/1984 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 09/27/1984 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/28/1984 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1983 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/20/1980 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 01/02/1981 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/25/1976 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
NOR-QD
TABLET;ORAL-28; 0.35MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAMILA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 076177 | DR REDDYS LABS SA |
| HEATHER | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 090454 | GLENMARK PHARMS LTD |
| INCASSIA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 207304 | AUROBINDO PHARMA |
| NOR-QD | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | Yes | AB1 | 017060 | TEVA BRANDED PHARM |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 091325 | LUPIN LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201483 | MYLAN LABS LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 206807 | NAARI PTE LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 202014 | NOVAST LABS |