Drugs@FDA: FDA Approved Drug Products
Company: APIL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOESTRIN 21 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | 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 |
|---|---|---|---|---|---|---|---|
| 10/01/1976 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017876Orig1s036,017354Orig1s051,017875s037,017355Orig1s053ltr.pdf | |
| 09/26/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/2003 | SUPPL-32 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17354slr044,17355slr046,17875slr032,17876slr031ltr.pdf |
| 03/31/1999 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/1997 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1995 | SUPPL-24 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/02/1994 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/27/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1996 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/09/1993 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/22/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/16/1988 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/13/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/22/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/17/1985 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1981 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/08/1981 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/10/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/14/1978 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1977 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017354s051,017355s053,017875s037,017876s036lbl.pdf |
LOESTRIN 21 1.5/30
TABLET;ORAL-21; 0.03MG;1.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AUROVELA 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 207581 | AUROBINDO PHARMA LTD |
| GILDESS 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 077075 | VINTAGE PHARMS LLC |
| JUNEL 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 076381 | BARR |
| LARIN 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 202996 | NOVAST LABS |
| LOESTRIN 21 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 017875 | APIL |
| MICROGESTIN 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 075548 | MAYNE PHARMA |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 202770 | MYLAN LABS LTD |
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