Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
ampicillin | Injectable;Injection | Strides Arcolab Ltd | Approval | |
acetazolamide | Capsule, Extended Release;Oral | Duramed Pharms Barr | Manufacturing Change or Addition | |
rivastigmine tartrate | Capsule;Oral | Novartis | Manufacturing Change or Addition | |
gatifloxacin | Solution; Ophthalmic | Hi-Tech Pharmacal | Tentative Approval | |
phentolamine mesylate | Injectable;Injection | Septodont Holding | Manufacturing Change or Addition | |
boceprevir | Capsule;Oral | Merck Sharp Dohme | Efficacy Supplement with Clinical Data to Support | |
zolmitriptan | Tablet; Oral | Invagen Pharms | Approval |
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