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AMANTADINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Amantadine Hydrochloride Syrup USP, 50 mg/5 mL, Carolina Medical Products Co. ANDA 75-819 9/11/02 Amantadine Hydrochloride Syrup USP, 50 mg and 5 mL Morton Grove ANDA 75-060 12/24/98 12/24/98 Amantadine Hydrochloride Tablets, 100 mg, Upsher-Smith , ANDA 76-186 Symmetrel (Amantadine Hydrochloride) Syrup, Endo NDA-17-118/S-017 AMANTADINE HYDROCHLORIDE Capsule; 100MG AMANTADINE HCL Geneva 070589 AMANTADINE HYDROCHLORIDE Capsule; 100MG AMANTADINE HCL USL 072655 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL ALPHARMA 075819 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL CAROLINA MEDCL 073115 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL Copley 016023 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML SYMMETREL ENDO 074170 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL HI TECH 074028 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL Mikart 075060 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL Morton Grove 074509 AMANTADINE HYDROCHLORIDE Syrup; 50MG/5ML AMANTADINE HCL ASSOC 018101 AMANTADINE HYDROCHLORIDE Tablet; 100MG SYMMETREL ENDO 076186 AMANTADINE HYDROCHLORIDE Tablet; 100MG AMANTADINE HCL USL Symmetrel (Amantadine Hydrochloride) Syrup & Tablets, Endo Amantadine Hydrochloride Syrup, Silarx Pharmaceuticals, Approval | Amantadine Hydrochloride Capsule, Amide Pharma, Approval | Amantadine Hydrochloride Oral Solution, Vintage Pharma, Approval | Symmetrel (amantadine) syrup, Endo Pharma, Labeling Revision | Symmetrel (amantadine) tablets, Endo Pharma, Labeling Revision | Amantadine Hydrochloride Capsules, Banner Pharmacaps, Inc., Approval | Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision | Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision | Symmetrel (amantadine hydrochloride) Syrup, Endo Pharmaceuticals, Labeling Revision | Symmetrel (amantadine hydrochloride) Tablets, Endo Pharmaceuticals, Labeling Revision

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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