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Details for New Drug Application (NDA): 205931
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NDA 205931 describes ACTICLATE, which is a drug marketed by Almirall and is included in two NDAs. Additional details are available on the ACTICLATE profile page.
The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline hyclate profile page.
The generic ingredient in ACTICLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Additional details are available on the doxycycline hyclate profile page.
Summary for 205931
| Tradename: | ACTICLATE |
| Applicant: | Almirall |
| Ingredient: | doxycycline hyclate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Jul 25, 2014 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Jul 25, 2014 | TE: | AB | RLD: | Yes | ||||
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