Details for New Drug Application (NDA): 075329
✉ Email this page to a colleague
NDA 075329 describes MICONAZOLE NITRATE COMBINATION PACK, which is a drug marketed by L Perrigo Co and is included in one NDA. It is available from seventeen suppliers. Additional details are available on the MICONAZOLE NITRATE COMBINATION PACK profile page.
The generic ingredient in MICONAZOLE NITRATE COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
The generic ingredient in MICONAZOLE NITRATE COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 075329
| Tradename: | MICONAZOLE NITRATE COMBINATION PACK |
| Applicant: | L Perrigo Co |
| Ingredient: | miconazole nitrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075329
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MICONAZOLE NITRATE COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 075329 | ANDA | L. Perrigo Company | 0113-0081 | 0113-0081-00 | 1 KIT in 1 CARTON (0113-0081-00) * 1 BLISTER PACK in 1 KIT / 3 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE |
| MICONAZOLE NITRATE COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 075329 | ANDA | Walgreen Company | 0363-0081 | 0363-0081-00 | 1 KIT in 1 CARTON (0363-0081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | Strength | 2%,200MG | ||||
| Approval Date: | Apr 20, 1999 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
