Drugs@FDA: FDA Approved Drug Products

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All Approvals
July 1968

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on November 15, 2018.

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 MYLAN 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 PHARMACIA AND UPJOHN Labeling Approval
07/31/1968 PENICILLIN-VK
ANDA #060456
ORIG-1 PENICILLIN V POTASSIUM TEVA Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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