AFATINIB DIMALEATE
HETERO LABS LTD V · AFATINIB DIMALEATE
Open FDA's page for this record- Application number
- ANDA210750
- Sponsor name
- HETERO LABS LTD V
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20260714
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- AFATINIB DIMALEATE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- AFATINIB DIMALEATE
- Strength
- EQ 30MG BASE
- Product number
- 003
- Reference drug
- No
- Brand name
- AFATINIB DIMALEATE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- AFATINIB DIMALEATE
- Strength
- EQ 40MG BASE
- Product number
- 001
- Reference drug
- No
- Brand name
- AFATINIB DIMALEATE
- Reference standard
- No
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- AFATINIB DIMALEATE
- Strength
- EQ 20MG BASE
- Harmonized identifiers (openFDA)
- Application number
- ANDA210750
- Brand name
- AFATINIB
- Generic name
- AFATINIB
- Manufacturer name
- Camber Pharmaceuticals, Inc.
- Product NDC
- 31722-781, 31722-782, 31722-783
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- AFATINIB DIMALEATE
- RxCUI
- 1430446, 1430451, 1430455
- SPL ID
- 5a8ec67a-afb9-4b6b-e063-6394a90adfc6
- SPL set ID
- ec5b9e00-3eab-4dbd-9bb3-75865b1af485
- Package NDC
- 31722-781-30, 31722-782-30, 31722-783-30
- UNII
- V1T5K7RZ0B