規制動向

The FDA has discontinued two injectable testosterone enanthate products from Watson Labs, listed under ANDA083667.

The FDA has processed application ANDA084026 for Watson Labs' oral chlorothiazide 500 mg tablet, currently listed as discontinued.

The FDA has approved ANDA 085767 for a 35 mg oral tablet of phendimetrazine tartrate submitted by Watson Labs; the product is listed as discontinued.

The FDA has approved ANDA 088750 for a 2.5 mg oral tablet of methyclothiazide submitted by Watson Labs; the product is listed as discontinued.

The FDA granted approval for ANDA 085231, an oral tablet containing 25 mg pyrilamine maleate, submitted by Watson Labs. The product is listed as discontinued.

Watson Labs' diphenhydramine hydrochloride injectable (product 001) is recorded by the FDA under ANDA083533 as discontinued and not a reference drug.

The FDA has granted approval (ANDA081213) for Watson Labs' ESTROPIPATE 0.75 mg oral tablet, with several labeling and manufacturing submissions approved.

FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.

The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.

The FDA records show that Watson Labs' potassium chloride injectable (3 mEq/mL) under ANDA 086210 is listed with a discontinued marketing status.

The FDA has approved ANDA085790 for an oral 100 mg Isoniazid tablet submitted by Watson Labs. The product is currently listed as discontinued.

FDA records ANDA087397 for Watson Labs' oral tablet BETHANECHOL CHLORIDE 50 mg, currently marked discontinued.