Details for New Drug Application (NDA): 063009
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The generic ingredient in MINOCYCLINE HYDROCHLORIDE is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 063009
Tradename: | MINOCYCLINE HYDROCHLORIDE |
Applicant: | Zydus |
Ingredient: | minocycline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 063009
Physiological Effect | Decreased Prothrombin Activity |
Medical Subject Heading (MeSH) Categories for 063009
Suppliers and Packaging for NDA: 063009
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 063009 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-317 | 68382-317-01 | 100 CAPSULE in 1 BOTTLE (68382-317-01) |
MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 063009 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-318 | 68382-318-18 | 50 CAPSULE in 1 BOTTLE (68382-318-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 2, 1992 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
Approval Date: | Aug 12, 2003 | TE: | AB | RLD: | No |
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