Approvals (Drugs@FDA)

MINOXIDIL (FOR MEN), MINOXIDIL (FOR WOMEN)

TARO · MINOXIDIL

ANDA209074Generic (ANDA)Over-the-counter
Open FDA's page for this record
Application number
ANDA209074
Sponsor name
TARO
Submissions
  1. Submission type
    ORIG
    Submission number
    2
    Submission status
    AP
    Submission status date
    20190422
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      57323
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209074Orig1s000TAltr.pdf
      Date
      20190122
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    9
    Submission status
    AP
    Submission status date
    20260904
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20260904
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20191204
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  5. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20181231
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      58292
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209074Orig1s000TAltr.pdf
      Date
      20190411
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20191204
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    MINOXIDIL (FOR MEN)
    Reference standard
    No
    Dosage form
    AEROSOL, FOAM
    Route
    TOPICAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      MINOXIDIL
      Strength
      5%
  2. Product number
    002
    Reference drug
    No
    Brand name
    MINOXIDIL (FOR WOMEN)
    Reference standard
    No
    Dosage form
    AEROSOL, FOAM
    Route
    TOPICAL
    Marketing status
    Over-the-counter
    Active ingredients
    1. Name
      MINOXIDIL
      Strength
      5%
Harmonized identifiers (openFDA)
Application number
ANDA209074
Brand name
MINOXIDIL, MINOXIDIL (FOR MEN), MINOXIDIL 5% (FOR MEN), MINOXIDIL (FOR WOMEN), MINOXIDIL 5 PERCENT (FOR WOMEN), REGOXIDINE (FOR WOMEN), GEMACHLICH ZUHAUSE HAIR GROWTH FOAM (MEN), REGOXIDINE (FOR MEN)
Generic name
MINOXIDIL FOAM 5% (WOMENS), MINOXIDIL, HAIR GROWTH FOAM (MEN)
Manufacturer name
Clarity Cosmetics Inc., SCIENTIFIC HAIR RESEARCH, LLC, Kroger Company, RESTORATION HOLDINGS, LLC, Walgreen Company, SPAZI INC., TARGET Corporation, PROFECTUS BEAUTY LLC, CVS Pharmacy, Virtue Labs, LLC, Innovus Pharmaceuticals, Inc., Guangdong Quadrant Ecological Technology Co., Ltd., Thirty MADISON, Inc.
Product NDC
84382-001, 69113-128, 59450-210, 82796-100, 0363-9090, 82376-6007, 11673-158, 70550-605, 51316-212, 0363-9091, 59450-211, 11673-157, 80855-201, 57483-540, 82376-6006, 76986-008, 51316-213, 57483-530, 69113-129, 71713-091
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
MINOXIDIL
RxCUI
645146, 2264763
SPL ID
5155446f-5934-e3b4-e063-6394a90adc2d, 1c5ccd0b-f7f2-89c9-e063-6294a90a43de, 9a38a0c9-f2c8-489d-9dbd-9f0a0990de13, 28f9ca10-20c6-b301-e063-6294a90af33c, 5076e3b7-04a0-40ce-91f9-dc63e9f14b9f, 78f0bcf6-b1b3-4f5b-a608-8f1fb0cfd2ca, 163b27c3-d12e-e049-e063-6294a90a165c, 24fea157-1a8d-4e35-8575-104eecb09af1, 4ed0bac5-7a48-37f6-e063-6394a90a2799, 60644c86-9dd0-422d-a4a9-262e3e5c7231, 41419988-5dbf-4f47-92d0-0f6f6b6513e9, 18ac1abd-35d5-8a92-e063-6394a90aca36, 3a228a78-03ce-991c-e063-6394a90adfa8, 61359d4f-de10-41f1-a795-f2ae3bda5b1d, 165062dd-5814-484a-a857-bef70f754f64, 3abe6f17-17ee-e25c-e063-6294a90a4d4d, 4ed0a396-9500-ac11-e063-6294a90a3b98, 36bf641f-2d8d-44ee-a5db-36d1135eebeb, 1c5b0624-6f31-a058-e063-6394a90a0612, 19f93b56-e00a-42ee-8255-7d47f10fd273
SPL set ID
1b54eca8-4a96-1b5e-e063-6394a90a7b94, 5b8fe2d9-c7c5-4563-82f2-3d6bff08b830, 8346788b-88b3-45c6-8c27-b34a810154fb, e18223ad-642e-81a5-e053-2a95a90a0752, 39526f7d-5e39-4e2e-8689-94b76ddbc462, facdb1c2-c36e-4bcc-a821-f8bad8bb17aa, 3a6bef39-1d8e-4ce3-9484-becd294566da, b307bcb7-4659-4dd7-86aa-00b3735f5844, f6d90382-dc51-480c-a46c-bad041915d07, 8a32828d-1591-478d-aed3-5159232675b4, c443fadd-669e-4d29-8b11-ef3c022ca6f4, 5505e1b2-8c9b-457c-8291-cb8a9c1f6b10, 85a9d343-1135-4296-96b5-fabab6b834f9, b60cc177-700c-4007-be1a-2cb74824e657, 2b6abc4d-3596-4411-a9f8-77c338c99a5d, 3abe6f17-17ed-e25c-e063-6294a90a4d4d, b10eb8fd-8301-4c38-af4c-220fe5c3b592, 43b58fd3-81a7-4e64-81f3-9d9acfbf6819, 19603dd4-2099-479d-9e6e-14c5d1c49928, 985ba944-147c-4207-b34b-ede702c3d704
Package NDC
84382-001-04, 69113-128-01, 69113-128-03, 59450-210-01, 59450-210-03, 82796-100-01, 0363-9090-01, 0363-9090-03, 82376-6007-8, 82376-6007-2, 11673-158-04, 11673-158-08, 70550-605-04, 51316-212-01, 51316-212-03, 51316-212-30, 51316-212-10, 0363-9091-01, 0363-9091-03, 59450-211-01, 59450-211-02, 11673-157-01, 11673-157-03, 11673-157-09, 80855-201-05, 80855-201-06, 57483-540-31, 82376-6006-8, 82376-6006-3, 76986-008-01, 51316-213-01, 51316-213-10, 51316-213-02, 57483-530-31, 69113-129-01, 69113-129-02, 71713-091-30
Nui
N0000175379, N0000175564
Pharm class pe
Arteriolar Vasodilation [PE]
Pharm class epc
Arteriolar Vasodilator [EPC]
UNII
5965120SH1
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.