Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090454
Company: GLENMARK PHARMS LTD
Company: GLENMARK PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HEATHER | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
04/23/2010 | 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 |
---|---|---|---|---|---|
03/29/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
12/03/2012 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
HEATHER
TABLET;ORAL-28; 0.35MG
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CAMILA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 076177 | DR REDDYS LABS SA |
HEATHER | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 090454 | GLENMARK PHARMS LTD |
INCASSIA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 207304 | AUROBINDO PHARMA |
NOR-QD | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | Yes | AB1 | 017060 | TEVA BRANDED PHARM |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 091325 | LUPIN LTD |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 206807 | NAARI PTE LTD |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 202014 | NOVAST LABS |
NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201483 | XIROMED |