THEOPHYLLINE
ZYDUS LIFESCIENCES · THEOPHYLLINE
Open FDA's page for this record- Application number
- ANDA218063
- Sponsor name
- ZYDUS LIFESCIENCES
- Submissions
- Submission type
- ORIG
- Submission number
- 1
- Submission status
- AP
- Submission status date
- 20240521
- Review priority
- STANDARD
- Submission class code
- UNKNOWN
- Products
- Product number
- 002
- Reference drug
- No
- Brand name
- THEOPHYLLINE
- Reference standard
- No
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- THEOPHYLLINE
- Strength
- 450MG
- Product number
- 001
- Reference drug
- No
- Brand name
- THEOPHYLLINE
- Reference standard
- No
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Te code
- AB
- Active ingredients
- Name
- THEOPHYLLINE
- Strength
- 300MG
- Harmonized identifiers (openFDA)
- Application number
- ANDA218063
- Brand name
- THEOPHYLLINE
- Generic name
- THEOPHYLLINE
- Manufacturer name
- Zydus Lifesciences Limited, Viona Pharmaceuticals Inc
- Product NDC
- 70771-1782, 70771-1783, 72578-173, 72578-174
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- THEOPHYLLINE ANHYDROUS
- RxCUI
- 314241, 317769
- SPL ID
- 86fdabb8-c881-4695-8127-59b26998e365, 1e5a0f45-86aa-498a-9cc3-9f7acc210ed6
- SPL set ID
- 7339f98d-b996-4e20-a7a7-315fd2a9fa4d, abdfb9b9-9402-4761-9347-8eb1c4d86242
- Package NDC
- 70771-1782-1, 70771-1783-1, 72578-173-01, 72578-174-01
- Nui
- N0000175790, M0023046
- Pharm class epc
- Methylxanthine [EPC]
- Pharm class cs
- Xanthines [CS]
- UNII
- 0I55128JYK