Details for New Drug Application (NDA): 075288
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NDA 075288 describes LOW-OGESTREL-28, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from three suppliers. Additional details are available on the LOW-OGESTREL-28 profile page.
The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
The generic ingredient in LOW-OGESTREL-28 is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 075288
| Tradename: | LOW-OGESTREL-28 |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | ethinyl estradiol; norgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075288
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOW-OGESTREL-21 | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075288 | ANDA | Mayne Pharma Inc. | 51862-564 | 51862-564-06 | 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01) |
| LOW-OGESTREL-21 | ethinyl estradiol; norgestrel | TABLET;ORAL-21 | 075288 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1637 | 53002-1637-1 | 1 BLISTER PACK in 1 PACKAGE (53002-1637-1) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-21 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Jul 28, 1999 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Jul 28, 1999 | TE: | AB | RLD: | No | ||||
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