Details for New Drug Application (NDA): 202099
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NDA 202099 describes ZENATANE, which is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ZENATANE profile page.
The generic ingredient in ZENATANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
The generic ingredient in ZENATANE is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 202099
| Tradename: | ZENATANE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | isotretinoin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202099
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZENATANE | isotretinoin | CAPSULE;ORAL | 202099 | ANDA | Dr. Reddy's Laboratories Limited | 55111-113 | 55111-113-78 | 10 BLISTER PACK in 1 CARTON (55111-113-78) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) |
| ZENATANE | isotretinoin | CAPSULE;ORAL | 202099 | ANDA | Dr. Reddy's Laboratories Limited | 55111-113 | 55111-113-81 | 3 BLISTER PACK in 1 CARTON (55111-113-81) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK (55111-113-79) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 25, 2013 | TE: | AB1 | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Mar 25, 2013 | TE: | AB1 | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 40MG | ||||
| Approval Date: | Mar 25, 2013 | TE: | AB1 | RLD: | No | ||||
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