Approvals (Drugs@FDA)

DOXYCYCLINE HYCLATE

SUN PHARM INDUSTRIES · DOXYCYCLINE HYCLATE

ANDA062676Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA062676
Sponsor name
SUN PHARM INDUSTRIES
Submissions
  1. Submission type
    SUPPL
    Submission number
    42
    Submission status
    AP
    Submission status date
    20150910
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    40
    Submission status
    AP
    Submission status date
    20130724
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  3. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    20020226
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    19970421
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  5. Submission type
    SUPPL
    Submission number
    14
    Submission status
    AP
    Submission status date
    20000516
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  6. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20030401
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    19930706
    Submission class code
    LABELING
    Submission class code description
    Labeling
  8. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    19990720
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  9. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    19930112
    Submission class code
    LABELING
    Submission class code description
    Labeling
  10. Submission type
    SUPPL
    Submission number
    57
    Submission status
    AP
    Submission status date
    20250401
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  11. Submission type
    SUPPL
    Submission number
    10
    Submission status
    AP
    Submission status date
    19971205
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
  12. Submission type
    SUPPL
    Submission number
    49
    Submission status
    AP
    Submission status date
    20180515
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  13. +19 more not shown
Products
  1. Product number
    002
    Reference drug
    No
    Brand name
    DOXYCYCLINE HYCLATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DOXYCYCLINE HYCLATE
      Strength
      EQ 50MG BASE
  2. Product number
    001
    Reference drug
    No
    Brand name
    DOXYCYCLINE HYCLATE
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      DOXYCYCLINE HYCLATE
      Strength
      EQ 100MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA062676
Brand name
DOXYCYCLINE HYCLATE
Generic name
DOXYCYCLINE HYCLATE
Manufacturer name
Sun Pharmaceutical Industries, Inc.
Product NDC
53489-118, 53489-119, 53489-120
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
DOXYCYCLINE HYCLATE
RxCUI
1649405, 1649988, 1650143
SPL ID
53577734-d479-e32b-e063-6394a90a7933
SPL set ID
214a9cfe-a522-4022-81d4-e59f447401fe
Package NDC
53489-118-02, 53489-118-05, 53489-119-02, 53489-119-05, 53489-120-02, 53489-120-05, 53489-120-60, 53489-120-01
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.