Exhibit 4. Examples of Pre-1938 Drugs That Remained on the Market as Unapproved Drugs [15].

Acetaminophen, codeine phosphate, and caffeine capsules and tablets Amobarbital sodium capsules Amyl nitrate inhalant Chloral hydrate capsules, syrup, and suppositories Codeine phosphate injection, oral solution, and tablets Codeine sulfate tablets Colchicine injection and tablets Digitoxin tablets Digoxin elixir and tablets Ephedrine sulfate capsules and injection Ergonovine maleate injection and tablets Ergotamine tartrate tablets Hydrocodone bitartrate tablets Hydrocodone bitartrate, aspirin, and caffeine tablets Hydromorphone hydrochloride suppositories Levothyroxine sodium for injection

Morphine sulfate oral solution and tablets Nitroglycerin sublingual tablets Opium tincture Oxycodone tablets Oxycodone hydrochloride oral solution Paregoric Phenazopyridine hydrochloride tablets Phenobarbital capsules, elixir, and tablets Phenobarbital sodium injection Pilocarpine hydrochloride ophthalmic solution Potassium bicarbonate effervescent tablets for oral solution Potassium chloride oral solution Potassium gluconate elixir and tablets Potassium iodide oral solution Salsalate capsules Sodium fluoride oral solution and tablets Thyroid tablets