Drugs@FDA: FDA-Approved Drugs
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRI-NORINYL 21-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| TRI-NORINYL 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-28 | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/1984 | 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 |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018977s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018977Orig1s043ltr.pdf | |
| 08/09/2017 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018977s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018977Orig1s041ltr.pdf | |
| 08/15/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/14/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/14/1999 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1996 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/27/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/19/1990 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1989 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/17/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/25/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/16/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 11/13/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/29/2022 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018977s043lbl.pdf | |
| 08/09/2017 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018977s041lbl.pdf |
TRI-NORINYL 21-DAY
There are no Therapeutic Equivalents.
TRI-NORINYL 28-DAY
TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ARANELLE | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 076783 | BARR |
| TRI-NORINYL 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG | TABLET;ORAL-28 | Prescription | Yes | AB | 018977 | DR REDDYS LABS SA |