Details for New Drug Application (NDA): 076225
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NDA 076225 describes ERRIN, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from two suppliers. Additional details are available on the ERRIN profile page.
The generic ingredient in ERRIN 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 ERRIN 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 076225
| Tradename: | ERRIN |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERRIN | norethindrone | TABLET;ORAL-28 | 076225 | ANDA | Proficient Rx LP | 71205-526 | 71205-526-28 | 1 BLISTER PACK in 1 CARTON (71205-526-28) / 28 TABLET in 1 BLISTER PACK |
| ERRIN | norethindrone | TABLET;ORAL-28 | 076225 | ANDA | Dr. Reddy's Labratories Inc. | 75907-075 | 75907-075-32 | 3 BLISTER PACK in 1 CARTON (75907-075-32) / 28 TABLET in 1 BLISTER PACK (75907-075-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Oct 21, 2002 | TE: | AB2 | RLD: | No | ||||
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