Drugs@FDA: FDA-Approved Drugs
Company: MAYNE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
01/29/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/26/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/21/2002 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/31/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/27/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/08/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/01/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
11/04/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
08/10/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/15/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/28/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
11/19/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
09/28/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
02/25/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |
NORETHINDRONE AND ETHINYL ESTRADIOL
TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYONANZ | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 207055 | AUROBINDO PHARMA LTD |
NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 070686 | MAYNE PHARMA |
NORTREL 0.5/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 072695 | BARR |
WERA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-28 | Prescription | No | AB | 091204 | NOVAST LABS LTD |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English