Current Report Filing (8-k)
September 12 2019 - 4:34PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
September 12, 2019 (September 10, 2019)
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its
charter)
Nevada
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001-15697
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22-3542636
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS
Employer Identification
No.)
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165 Ludlow Avenue, Northvale, New Jersey
07647
(Address of principal executive offices)
(201) 750-2646
(Registrant’s telephone number, including
area code)
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to
Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant
is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant
to Section 12(b) of the Act:
Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Item 7.01
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Regulation
FD Disclosure.
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On September 12, 2019, in a press release,
Elite Pharmaceuticals, Inc., or Elite, reported that it received approval from the US Food and Drug Administration (FDA) for a
generic version of for an Abbreviated New Drug Application (ANDA) for a generic version of Tylenol® with Codeine (acetaminophen
and codeine phosphate) 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.
A copy of the press release is furnished as
Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release
furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities
Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall
be expressly set forth by specific reference in any such filing.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits.
1
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: September 12, 2019
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ELITE PHARMACEUTICALS, INC.
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By:
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/s/ Nasrat
Hakim
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Nasrat Hakim, President and CEO
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