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BaclofenDrug - Baclofen The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
Active Ingredient(s) -
Baclofen
Strength -
20MG
Applicant -
ALPHAPHARM
New Drug Application (NDA) Number -
077121
Product Number -
002
Therapeutic Equivalence (TE) Code -
AB
Approval Date -
Jul 29, 2005
Reference Listed Drug (RLD) -
No
Type -
RX
Applicant Full Name -
Alphapharm Party Ltd
Baclofen
Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic
Mycitracin 500 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Lanabiotic 500 Units/gm;5,000 Units/gm Disc; Topical Lioresal 0.05mg/ml Injectable; Intrathecal Lioresal 0.5mg/ml Injectable; Intrathecal Lioresal 2mg/ml Injectable; Intrathecal Kemstro 10mg Tablet, Orally Disintegrating; Oral Kemstro 20mg Tablet, Orally Disintegrating; Oral Baclofen 10mg Tablet; Oral Baclofen 20mg Tablet; Oral NewDrugInformation |