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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
July 1968

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on April 19, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/01/1968 PATHOCIL
NDA #050011
SUPPL-6 DICLOXACILLIN SODIUM WYETH AYERST Labeling Approval
07/02/1968 CORTISPORIN
NDA #050168
SUPPL-45 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE MONARCH PHARMS Labeling Approval
07/03/1968 NEOSPORIN
ANDA #060582
ORIG-1 GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE MONARCH PHARMS Approval
07/03/1968 PENICILLIN-VK
ANDA #060711
ORIG-1 PENICILLIN V POTASSIUM TEVA Approval
07/12/1968 PATHOCIL
NDA #050092
SUPPL-5 DICLOXACILLIN SODIUM WYETH AYERST Manufacturing (CMC) Approval
07/12/1968 LINCOCIN
NDA #050316
SUPPL-28 LINCOMYCIN HYDROCHLORIDE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
07/17/1968 TETRACYCLINE HYDROCHLORIDE
ANDA #060783
ORIG-1 TETRACYCLINE HYDROCHLORIDE AUROBINDO PHARMA USA Approval
07/19/1968 KENACORT
NDA #011283
SUPPL-3 TRIAMCINOLONE DELCOR ASSET CORP Supplement Approval
07/24/1968 LINCOCIN
NDA #050317
SUPPL-57 LINCOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
07/31/1968 PENICILLIN-VK
ANDA #060456
ORIG-1 PENICILLIN V POTASSIUM TEVA Approval
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