Details for New Drug Application (NDA): 090454
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NDA 090454 describes HEATHER, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the HEATHER profile page.
The generic ingredient in HEATHER is norethindrone. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
The generic ingredient in HEATHER is norethindrone. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 090454
| Tradename: | HEATHER |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090454
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEATHER | norethindrone | TABLET;ORAL-28 | 090454 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-303 | 68462-303-29 | 3 BLISTER PACK in 1 CARTON (68462-303-29) / 28 TABLET in 1 BLISTER PACK (68462-303-84) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Apr 23, 2010 | TE: | AB1 | RLD: | No | ||||
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