Details for New Drug Application (NDA): 209844
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NDA 209844 describes LYMEPAK, which is a drug marketed by Chartwell Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the LYMEPAK profile page.
The generic ingredient in LYMEPAK is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in LYMEPAK is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 209844
| Tradename: | LYMEPAK |
| Applicant: | Chartwell Pharma |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209844
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYMEPAK | doxycycline hyclate | TABLET;ORAL | 209844 | NDA | Chartwell RX, LLC. | 62135-596 | 62135-596-87 | 3 BLISTER PACK in 1 CARTON (62135-596-87) / 14 TABLET, FILM COATED in 1 BLISTER PACK (62135-596-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 15, 2018 | TE: | RLD: | Yes | |||||
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