Approvals (Drugs@FDA)

TADALAFIL

ALEMBIC · TADALAFIL

ANDA204809Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA204809
Sponsor name
ALEMBIC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20190326
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
  2. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20250219
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
Products
  1. Product number
    004
    Reference drug
    No
    Brand name
    TADALAFIL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TADALAFIL
      Strength
      20MG
  2. Product number
    002
    Reference drug
    No
    Brand name
    TADALAFIL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TADALAFIL
      Strength
      5MG
  3. Product number
    003
    Reference drug
    No
    Brand name
    TADALAFIL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TADALAFIL
      Strength
      10MG
  4. Product number
    001
    Reference drug
    No
    Brand name
    TADALAFIL
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB1
    Active ingredients
    1. Name
      TADALAFIL
      Strength
      2.5MG
Harmonized identifiers (openFDA)
Application number
ANDA204809
Brand name
TADALAFIL
Generic name
TADALAFIL
Manufacturer name
Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited
Product NDC
62332-177, 62332-178, 62332-179, 62332-180, 46708-177, 46708-178, 46708-179, 46708-180
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
TADALAFIL
RxCUI
402019, 403957, 484814, 757707
SPL ID
76b22a5c-175e-433e-bd1e-5fefb0a78d5f, 53d81162-1774-48a1-b19b-f2b0e2d1020a
SPL set ID
abcb2cda-9b3f-45f6-ad5f-c2370b0dd114, 741102c1-8809-44d4-9098-3dc8c0604764
Package NDC
62332-177-15, 62332-177-30, 62332-177-71, 62332-177-91, 62332-178-30, 62332-178-15, 62332-178-71, 62332-178-91, 62332-179-30, 62332-179-71, 62332-179-91, 62332-180-30, 62332-180-71, 62332-180-91, 46708-177-15, 46708-177-31, 46708-177-71, 46708-177-91, 46708-178-30, 46708-178-15, 46708-178-71, 46708-178-91, 46708-179-30, 46708-179-71, 46708-179-91, 46708-180-30, 46708-180-71, 46708-180-91
Nui
N0000175599, N0000020026
Pharm class epc
Phosphodiesterase 5 Inhibitor [EPC]
Pharm class moa
Phosphodiesterase 5 Inhibitors [MoA]
UNII
742SXX0ICT
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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.