0378-1905 : Roflumilast 500 ug/1 Oral Tablet


NDC0378-1905
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Roflumilast
Dosage Form: Oral Tablet
Application #: ANDA208257
Rev. Date: 


NDC Package Codes:

  • 0378-1905-77: 90 TABLET IN 1 BOTTLE, PLASTIC (0378‑1905‑77)
  • 0378-1905-93: 30 TABLET IN 1 BOTTLE, PLASTIC (0378‑1905‑93)

Active Ingredients:

  • Roflumilast

Dosage Strength:

  • 500 ug/1

Pharmaceutical Classes:

  • Phosphodiesterase 4 Inhibitor [EPC]
  • Phosphodiesterase 4 Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0904-7399 Roflumilast 500 ug/1 Oral Tablet by Major Pharmaceuticals
  • 13668-476 Roflumilast 500 ug/1 Oral Tablet by Torrent Pharmaceuticals Limited
  • 31722-623 Roflumilast 500 ug/1 Oral Tablet by Camber Pharmaceuticals, Inc.
  • 31722-676 Roflumilast 250 ug/1 Oral Tablet by Camber Pharmaceuticals, Inc.
  • 42571-259 Roflumilast 500 ug/1 Oral Tablet by Micro Labs Limited
  • 42571-369 Roflumilast 250 ug/1 Oral Tablet by Micro Labs Limited
  • 43547-005 Roflumilast 500 ug/1 Oral Tablet by Solco Healthcare Us, LLC.
  • 59651-275 Roflumilast 500 ug/1 Oral Tablet by Aurobindo Pharma Limited
  • 60687-786 Roflumilast 500 ug/1 Oral Tablet by American Health Packaging
  • 64380-786 Roflumilast 500 ug/1 Oral Tablet by Strides Pharma Science Limited
  • 68382-624 Roflumilast 250 ug/1 Oral Tablet by Zydus Pharmaceuticals USA Inc.
  • 68382-969 Roflumilast 500 ug/1 Oral Tablet by Zydus Pharmaceuticals (Usa) Inc.
  • 70771-1673 Roflumilast 250 ug/1 Oral Tablet by Zydus Lifesciences Limited
  • 70771-1674 Roflumilast 500 ug/1 Oral Tablet by Cadila Healthcare Limited
  • 72205-200 Roflumilast 500 ug/1 Oral Tablet by Novadoz Pharmaceuticals LLC
  • 72205-201 Roflumilast 250 ug/1 Oral Tablet by Novadoz Pharmaceuticals LLC

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