Approvals (Drugs@FDA)

ROPINIROLE HYDROCHLORIDE

ALEMBIC LTD · ROPINIROLE HYDROCHLORIDE

ANDA090429Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA090429
Sponsor name
ALEMBIC LTD
Submissions
  1. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20200407
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    16
    Submission status
    AP
    Submission status date
    20260909
    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
    20151118
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20100324
  5. Submission type
    SUPPL
    Submission number
    19
    Submission status
    AP
    Submission status date
    20260909
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  6. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20200407
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  7. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20111031
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    006
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 4MG BASE
  2. Product number
    004
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 2MG BASE
  3. Product number
    002
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 0.5MG BASE
  4. Product number
    007
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 5MG BASE
  5. Product number
    005
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 3MG BASE
  6. Product number
    003
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 1MG BASE
  7. Product number
    001
    Reference drug
    No
    Brand name
    ROPINIROLE HYDROCHLORIDE
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      ROPINIROLE HYDROCHLORIDE
      Strength
      EQ 0.25MG BASE
Harmonized identifiers (openFDA)
Application number
ANDA090429
Brand name
ROPINIROLE
Generic name
ROPINIROLE
Manufacturer name
Alembic Pharmaceuticals Limited, Alembic Pharmaceuticals Inc.
Product NDC
46708-030, 46708-031, 46708-032, 46708-033, 46708-034, 46708-035, 46708-036, 62332-030, 62332-031, 62332-032, 62332-033, 62332-034, 62332-035, 62332-036
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
ROPINIROLE HYDROCHLORIDE
RxCUI
283858, 312845, 312846, 312847, 312849, 314208, 562704
SPL ID
aad4b153-ed5a-4781-ba0f-fb4bcf990057, 061e4779-5a53-4782-bb85-03abe1c98ce1
SPL set ID
9a25f575-09ab-4d32-b73e-5426f08c00c4, 6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c
Package NDC
46708-030-31, 46708-031-31, 46708-032-31, 46708-033-31, 46708-034-31, 46708-035-31, 46708-036-31, 62332-030-31, 62332-031-31, 62332-032-31, 62332-033-31, 62332-034-31, 62332-035-31, 62332-036-31
UNII
D7ZD41RZI9
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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.