Approvals (Drugs@FDA)

DOXYCYCLINE HYCLATE

SUN PHARM INDUSTRIES · DOXYCYCLINE HYCLATE

ANDA065134Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA065134
Sponsor name
SUN PHARM INDUSTRIES
Submissions
  1. Submission type
    SUPPL
    Submission number
    22
    Submission status
    AP
    Submission status date
    20250401
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20100119
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20050513
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    DOXYCYCLINE HYCLATE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DOXYCYCLINE HYCLATE
      Strength
      EQ 20MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA065134
Brand name
DOXYCYCLINE HYCLATE
Generic name
DOXYCYCLINE HYCLATE
Manufacturer name
Sun Pharmaceutical Industries, Inc.
Product NDC
53489-647
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DOXYCYCLINE HYCLATE
RxCUI
283535
SPL ID
31dd6775-5a9a-9e21-e063-6294a90aa546
SPL set ID
bff3f426-44fc-4dbf-96df-df44011103e8
Package NDC
53489-647-07, 53489-647-06, 53489-647-90, 53489-647-01, 53489-647-03, 53489-647-05, 53489-647-10
UNII
19XTS3T51U
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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.