Details for New Drug Application (NDA): 211328
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NDA 211328 describes HALOETTE, 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 HALOETTE profile page.
The generic ingredient in HALOETTE is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
The generic ingredient in HALOETTE is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
Summary for 211328
| Tradename: | HALOETTE |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | ethinyl estradiol; etonogestrel |
| Patents: | 0 |
Pharmacology for NDA: 211328
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 211328
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HALOETTE | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211328 | ANDA | Mayne Pharma Inc. | 51862-148 | 51862-148-03 | 3 POUCH in 1 CARTON (51862-148-03) / 21 d in 1 POUCH (51862-148-01) |
| HALOETTE | ethinyl estradiol; etonogestrel | RING;VAGINAL | 211328 | ANDA | Dr. Reddy's Labratories Inc. | 75907-088 | 75907-088-13 | 3 POUCH in 1 CARTON (75907-088-13) / 21 d in 1 POUCH (75907-088-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | RING;VAGINAL | Strength | 0.015MG/24HR;0.12MG/24HR | ||||
| Approval Date: | Aug 5, 2022 | TE: | AB | RLD: | No | ||||
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