Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209297
Company: GLENMARK PHARMS
Company: GLENMARK PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HAILEY 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 |
---|---|---|---|---|---|---|---|
06/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
HAILEY 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 |
HAILEY 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | No | AB | 209297 | GLENMARK PHARMS |
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 | Yes | AB | 017875 | TEVA BRANDED PHARM |
LOESTRIN FE 1.5/30 | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.03MG;1.5MG | TABLET;ORAL-21 | Prescription | Yes | AB | 017355 | TEVA BRANDED PHARM |
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 |
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