Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075288
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOW-OGESTREL-21 | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-21 | Discontinued | None | No | No |
LOW-OGESTREL-28 | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | 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 |
---|---|---|---|---|---|---|---|
07/28/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75288ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075288_norgestrel-and-ethinyl-estradiol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2022 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2022 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
08/09/2017 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/24/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/28/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75288_Norgestrel%20And%20Ethinyl%20Estradiol_Prntlbl.pdf |
LOW-OGESTREL-21
There are no Therapeutic Equivalents.
LOW-OGESTREL-28
TABLET;ORAL-28; 0.03MG;0.3MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CRYSELLE | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 075840 | DURAMED PHARMS BARR |
ELINEST | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 091105 | NOVAST LABS LTD |
LOW-OGESTREL-28 | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 075288 | DR REDDYS LABS SA |
TURQOZ | ETHINYL ESTRADIOL; NORGESTREL | 0.03MG;0.3MG | TABLET;ORAL-28 | Prescription | No | AB | 202980 | LUPIN LTD |